+ All Categories
Home > Documents > MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

Date post: 12-Sep-2021
Category:
Upload: others
View: 2 times
Download: 0 times
Share this document with a friend
367
410 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4] MINISTRY OF HEALTH AND FAMILY WELFARE (FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA) NOTIFICATION New Delhi, the 20, October, 2010 No. 2-15015/30/2010-FSSAI- the following draft of food Safety and Standards Regulation, 2010, which the Food safety and Standards Authority of India with previous approval of Central Government, proposes to make, in exercise of the powers conferred under section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), is hereby published as required by the section 92, for the information of all persons likely to be affected thereby, and notice is hereby given that the said draft regulation will be taken into consideration after the expiry of a period of thirty days from the date on which copies of the Official Gazette in which this notification is published, are made available to the public; Objections or suggestions, if any, may be addressed to the CEO, Food safety and Standards Authority of India, FDA Bhawan, Kotla road, New Delhi-110002 The objections and suggestions which may be received from any person with respect to the said draft regulations before the expiry of the period specified above will be considered by the Authority. DRAFT FOOD SAFETY AND STANDARDS REGULATIONS, 2010 CHAPTER 1 GENERAL Part 1.1: Title and commencement Regulation 1.1.1: These regulations may be called the Food Safety and Standards Regulations, 2010. Regulation 1.1.2: They shall extend to the whole of India. Part 1.2: Definitions Regulation 1.2.1: In these regulations unless the context otherwise requires: (1) “Act” means the Food Safety and Standards Act, 2006 (Act 34 of 2006); (2) “Best before” means the date which signifies the end of the period under any stated storage conditions during which the product shall remain fully marketable and shall retain any specific qualities for which tacit or express claims have been made and beyond that date. The food may still be perfectly safe to consume, though its quality may have diminished; and food can be sold after this date provided it is not unsafe. (3) “Date of manufacture” means the date on which the food becomes the product as described; (4) “Date of packaging” means the date on which the food is placed in the immediate container in which it will be ultimately sold; (5) “District” means a local area as defined by the Authority for the purpose of the Food safety and Standards Act, 2006. The district can be constituted on the basis of: (a) Concentration of specific category of food businesses which may need special attention (b) Risk assessment carried out by the Authority from time to time (c) Any other specific regulatory requirements (6) “Infant” means a child not more than twelve months of age; (7) “Licensing Authority” means the Designated Officer appointed under section 36 (i) of the Act by the food safety commissioner of the state or of the Food Authority for the local area and includes an officer to whom powers of issue of a licence has been delegated by the Designated Officer; (8) “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed graphic, perforated, stamped or impressed on or attached to container, cover, lid or crown of any food package. For the purpose of declaration of month and year of manufacture, the provisions under rule 6(B) of Standards of Weights and Measures (Packaged Commodities) Rules, 1977 shall apply.
Transcript
Page 1: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

410 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

MINISTRY OF HEALTH AND FAMILY WELFARE(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)

NOTIFICATION

New Delhi, the 20, October, 2010

No. 2-15015/30/2010-FSSAI- the following draft of food Safety and Standards Regulation, 2010, which the Foodsafety and Standards Authority of India with previous approval of Central Government, proposes to make, in exercise ofthe powers conferred under section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), is hereby published asrequired by the section 92, for the information of all persons likely to be affected thereby, and notice is hereby given thatthe said draft regulation will be taken into consideration after the expiry of a period of thirty days from the date on whichcopies of the Official Gazette in which this notification is published, are made available to the public;

Objections or suggestions, if any, may be addressed to the CEO, Food safety and Standards Authority of India, FDABhawan, Kotla road, New Delhi-110002

The objections and suggestions which may be received from any person with respect to the said draft regulationsbefore the expiry of the period specified above will be considered by the Authority.

DRAFT FOOD SAFETY AND STANDARDS REGULATIONS, 2010

CHAPTER 1GENERAL

Part 1.1: Title and commencement

Regulation 1.1.1: These regulations may be called the Food Safety and Standards Regulations, 2010.

Regulation 1.1.2: They shall extend to the whole of India.

Part 1.2: Definitions

Regulation 1.2.1: In these regulations unless the context otherwise requires:

(1) “Act” means the Food Safety and Standards Act, 2006 (Act 34 of 2006);

(2) “Best before” means the date which signifies the end of the period under any stated storage conditions duringwhich the product shall remain fully marketable and shall retain any specific qualities for which tacit or express claims havebeen made and beyond that date. The food may still be perfectly safe to consume, though its quality may have diminished;and food can be sold after this date provided it is not unsafe.

(3) “Date of manufacture” means the date on which the food becomes the product as described;

(4) “Date of packaging” means the date on which the food is placed in the immediate container in which it will beultimately sold;

(5) “District” means a local area as defined by the Authority for the purpose of the Food safety and Standards Act,2006. The district can be constituted on the basis of:

(a) Concentration of specific category of food businesses which may need special attention

(b) Risk assessment carried out by the Authority from time to time

(c) Any other specific regulatory requirements

(6) “Infant” means a child not more than twelve months of age;

(7) “Licensing Authority” means the Designated Officer appointed under section 36 (i) of the Act by the foodsafety commissioner of the state or of the Food Authority for the local area and includes an officer to whom powers ofissue of a licence has been delegated by the Designated Officer;

(8) “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked,embossed graphic, perforated, stamped or impressed on or attached to container, cover, lid or crown of any food package.For the purpose of declaration of month and year of manufacture, the provisions under rule 6(B) of Standards of Weightsand Measures (Packaged Commodities) Rules, 1977 shall apply.

Page 2: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 411

(9) “Lot number” or “code number” or “batch number” means the number either in numericals or alphabets or incombination thereof, representing the lot number or code number or batch number, being preceded by the words “Lot No”or “Lot” or “code number” or “Code” or Batch No” or “Batch” or any distinguishing prefix by which the food can betraced in manufacture and identified in distribution.

(10) “Multipiece package” means a package containing two or more individually packaged or labelled pieces of thesame commodity of identical quantity, intended for retail either in individual pieces or packages as a whole.

(11) “Non- Vegetarian Food” means an article of food which contains whole or part of any animal including birds,fresh water or marine animals or eggs or products of any animal origin, but not including milk or milk products, as aningredient;

(12) “Nutritional food” means the food claimed to be enriched with nutrients, such as, minerals or proteins orvitamins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance forIndians) or enzymes (within permissible limits);

(13) “Prepackaged” or “Pre-packed food”, means food, which is placed in a package of any nature, in such amanner that the contents cannot be changed without tampering it and which is ready for sale to the consumer.

Note: The expression “package” wherever it occurs in these Regulations, shall be construed as package containingpre-packed food articles.

(14) “Principal Display Panel” means that part of the container/package which is intended or likely to be displayedor presented or shown or examined by the customer under normal and customary conditions of display, sale or purchaseof the commodity contained therein.

(15) “Use – by date” or “Recommended last consumption date” or “Expiry date” means the date which signifies theend of the estimated period under any stated storage conditions, after which product probably will not have the qualityattributes normally expected by the consumers and the food shall not be marketable;

(16) “Vegetarian Food” means any article of Food other than Non- Vegetarian Food as defined in Regulaiton 1.2.1(11).

(17) “Wholesale package” means a package containing —(a) ‘a number of retail packages, where such first mentioned package is intended for sale, distribution or

delivery to an intermediary and is not intended for sale direct to a single consumer; or(b) a commodity of food sold to an intermediary in bulk to enable such intermediary to sell, distribute or deliver

such commodity of food to the consumer in smaller quantities.The expressions used in these Regulations but have not been defined herein shall have the meaning ascribed

to them in the Act or as provided in the regulations, chapters and Appendices.

CHAPTER 2FOOD AUTHORITY AND TRANSACTION OF BUSINESS

Part 2.1: Food Authority

Regulation 2.1.1: Salaries and terms and conditions of service of employees of Food Authority of IndiaRegulation 2.1.2: Procedure for transaction of business

Part 2.2: Central Advisory Committee

Regulation 2.2.1: Procedure for transaction of business

Part 2.3: Scientific Committee and Panels

Regulation 2.3.1: Procedure for establishment and operations of the Scientific CommitteeRegulation 2.3.2: Procedure for establishment and operations of the Scientific Panels

Part 2.4: Jurisdiction of Designated officerRegulation 2.4.1 The commissioner of Food Safety shall, by order, appoint the Designated officer, who shall not be

below the rank of a Sub- Divisional Officer, to be in-charge of food safety administration for each district as defined underRegulation 1.2.1 (5)

Page 3: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

412 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

CHAPTER 3LICENSING AND REGISTRATION OF FOOD BUSINESSES

Part 3.1 Definitions

In these Regulations, unless the context otherwise requires,—

Regulation 3.1.1 “Central Licensing Authority” means Designated Officer appointed by the Chief ExecutiveOfficer of the Food Authority of India in his capacity of Food Safety Commissioner.

Regulation 3.1.2 “Petty Food Manufacturer” means any food manufacturer, who

(a) manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporarystall holder; or

(b) such other food businesses including small scale or cottage or such other industries relating to foodbusiness or tiny food businesses with an annual turnover not exceeding Rs 12 lakhs and/or whose

(i) production capacity of food (other than milk and milk products and meat and meat products) does notexceed 100 kg/ltr per day or

(ii) production or procurement or collection of milk is up to 500 litres of milk per day or

(iii) slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less

Regulation 3.1.4 “Registering Authority” means Designated Officer/ Food Safety Officer or any official inPanchayat, Municipal Corporation or any other local body or Panchayat in an area, notified as such by the StateFood Safety Commissioner for the purpose of registration as specified in these Regulations.

Regulation 3.1.5 “State Licensing Authority” means Designated Officers appointed under Section 36(1) ofthe Act by the Food Safety Commissioner of a State or UT.

Words and expressions used herein and not defined, but defined under the Act or in any other regulations under the Act,shall have the meaning respectively assigned to them therein.

Part 3.2 Registration and License for Food Business

All Food Business Operators in the country will be registered or licensed in accordance with the procedures laiddown hereinafter without prejudice to the availability of safe and wholesome food for human consumption.

Regulation 3.2.1 Registration of petty food business

(1) Every petty food manufacturer shall register themselve with the Registering Authority by submitting anapplication for registration in Form A under Schedule 2 of these Regulations along with a fee as provided inSchedule 3.

(2) The Food Business Operator shall follow the basic hygiene and safety requirements provided in Schedule4 (Part I) of these Regulations and provide a self attested declaration of adherence to these requirements with theapplication in the format provided in Annexure-1 under Schedule 2

(3) The Registering Authority shall consider the application and may either grant registration or reject it withreasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application forregistration

(4) In the event of an inspection being ordered, the registration shall be granted by the Registering Authorityafter being satisfied with the safety, hygiene and sanitary conditions of the premises within a period of 30 days.

(5) If registration is not granted, or denied, or inspection not ordered within 7 days as provided in above subregulation (3) or no decision is communicated within 30 days as provided in above sub regulation (4), the FoodBusiness Operator may start his business, provided that it will be incumbent on the Food Business operator tocomply with any improvement suggested by the Registering Authority at any later time.

Provided that registration shall not be refused without giving the applicant an opportunity of being heard andfor reasons to be recorded in writing.

Page 4: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 413

(6) The Registering Authority shall issue a registration certificate and a photo identity card, which shall bedisplayed at a prominent place at all times within the premises or vehicle or cart or any other place where the personcarries on sale/manufacture of food in case of Petty Food Business.

(7) The Registering Authority or any officer or agency specifically authorized for this purpose shall carry outfood safety inspection of the registered establishments at least once in a year.

Regulation 3.2.2 License for food business

(1) Subject to Regulation 3.2.1, no person shall commence any food business unless he possesses a validlicense under these Regulations.

Provided that any person or Food Business Operator carrying on food business on the date of notification ofthese Regulations, under a license, registration or permission, as the case may be, under the Acts or Ordersmentioned in the Second Schedule of the Act shall enable the Licensing Authority to collect complete informationof all food establishments, get their existing license converted into the license/registration under these regulationsby making an application to the Licensing/Registering Authority within one year of notification of these Regulations.No license fee will have to be paid for the remaining period of the validity of the earlier license or registration grantedunder any of the said Acts or Orders Non-compliance with this provision by a Food Business Operator will attractpenalty under section 55 of the Act.

Provided further that any Food Business Operator holding Registration/License under any other Act/Orderas specified under schedule 2 of the FSS Act, 2006 with no specific validity or expiry date, and other wise entitiledto obtain a license under these regulations, shall have to apply and obtain a Registration/License under theseRegulations within one year from the date of notification by paying the applicable fees.

(2) Notwithstanding the provisions contained in Regulation 3.2.2(1) above or in any of the registration orlicense certificates issued under existing Acts or Orders mentioned in the second schedule of the Act, the LicensingAuthority, if it has reason to believe that the Food Business Operator has failed to comply with all or any of theconditions of the existing registration or license or the safety requirements given in Schedule 4, may give appropriatedirection to the Food Business Operator to comply with.

(3) License for commencing or carrying on food business, which falls under Schedule 1, shall be granted bythe Central Licensing Authority. For importing any type of food items, including food ingredients and additives, afood business Operator shall have to obtain a license from the Central Licensing Authority, Provided that FoodAuthority may through notification make such changes or modify the list given in the Schedule I as considerednecessary.

(4) License for commencing or carrying on food business, which are not covered under Schedule 1, shall begranted by the concerned State Licensing Authority.

(5) The Food Business Operator shall ensure that all conditions of license as provided in Annexure 2 of Form‘B’ in Schedule 2 and safety, sanitary and hygienic requirements provided in the Schedule 4 are complied with at alltimes .

Provided that no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article offood which has been subjected to the treatment of irradiation, except under a license obtained from Department ofAtomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996.

Provided further that the Licensing Authority shall ensure periodical food safety audit and inspection of thelicensed establishments through its own or authorised agencies.

Regulation 3.2.3 Application for license to the Licensing Authority

An application for the grant of a license shall be made in Form B of Schedule 2 to the concerned LicensingAuthority as specified in Regulation 3.2.2 (3) and 3.2.2 (4) and it will be accompanied by a self-attested declarationin the format provided in the Annexure-1 and copies of documents mentioned in the Annexure 2 of Schedule-2along with the applicable fees prescribed in Schedule 3.

Regulation 3.2.4 Processing of Application for license

(1) A license shall, subject to the provisions of these Regulations, be issued by the concerned LicensingAuthority within a period of 60 days from the date of receipt of the completed application along with all requireddocuments and fees.

Page 5: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

414 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) On the receipt of the completed application along with all required documents and fees, the concernedLicensing Authority shall issue a unique application number to each applicant that will be referred to in all futurecorrespondence between the Licensing Authority and the applicant.

(3) If, upon scrutiny of the application within 15 days from the date of receipt of the application, the concernedLicensing Authority requires any additional information with respect to an application or if the application isincomplete, the Licensing Authority may inform the applicant in writing, to furnish such additional information orcomplete the application, as the case may be, within 30 days from such notice.

(4) On receiving the complete information and documents the Licensing Authority shall direct the Food SafetyOfficer or any other person specially designated for such functions to inspect the premises in a manner andaccording to Regulations as laid down by the Food Authority. The Licensing Authority may issue a notice to theapplicant, if it deems fit, guiding food business Operator on necessary steps to be taken or changes or alteration tobe made in the premises in order to ensure general sanitary and hygienic conditions as specified in Schedule 4.

(5) Within a period of 30 days from receipt of an inspection report the concerned Licensing Authority shallconsider the application and may either grant or reject the license.

Provided that no applicant shall be refused a license without being given an opportunity of being heard andfor reasons to be recorded in writing.

(6) The Licensing Authority shall issue a License in Format C under Schedule 2 of these Regulations, a truecopy of which shall be displayed at a prominent place at all times within the premises where the Food BusinessOperator carries on the food business.

Regulation 3.2.5 Procedure for License in certain local areas

(1) A single license may be issued by the licensing authority for one or more articles of food and also fordifferent establishments or premises in the same local area including collection and chilling units run by milkcooperatives or its members.

(2) The Central Licensing Authority may after satisfying itself about the adequacy of the mechanism to ensurefood safety in a Government organization like Railways, Defense etc., with a large number of food establishments,authorise an officer of that organization to function as a Designated officer under sec. 36(3) of the Act who will beresponsible for the safety of the food served by those establishments and to ensure that all other conditions laiddown for running food business under the Act and these Regulations are complied with. Provided that the FoodAuthority may carry out food safety audit of these establishments once in a year through its own or accreditedagencies.

Regulation 3.2.6 Commencement of Business

An applicant may commence his food business and the concerned licensing Authority shall not deny theapplicant to commence such business if, from the date of making the completed application, a license is not issuedwithin 60 days or the applicant has not received any intimation of inadequacy under Regulation 3.2.4(3) or inspectionreport indicating defects from the concerned licensing authority under Regulation 3.2.4(4).

Regulation 3.2.7 Validity and Renewal of Registration and License(1) A Registration or license granted under these Regulations shall be valid and subsisting, unless otherwise

specified,for a period of 1 to 5 years as chosen by the Food Business Operator, from the date of issue of registration orlicense subject to remittance of fee applicable for the period and compliance with all conditions of license.(2) Any application for the renewal of a registration or license granted under these Regulations shall be made

in Form A or B of Schedule 2, as the case may be, not later than 30 days prior to the expiry date indicated in thelicense.

(3) The Registration or License shall continue to be in force till such time that the orders are passed on therenewal application which in no case shall be beyond 30 days from the date of expiry of registration or license.

(4) Any renewal application filed beyond the period mentioned under Regulation 3.2.7 (2) above but beforethe expiry date, shall be accompanied by a late fee of Rs 100 per day of delay

Page 6: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 415

(5) Any Registration or license for which renewal has not been applied for within the period mentioned inRegulation 3.2.7 (2) or 3.2.7 (4) above shall expire and the Food Business Operator shall stop all business activityat the premises. The Food Business Operator will have to apply for fresh Registration or license as provided inRegulation 3.2.1 and 3.2.3 as the case may be, if it wants to restart the business.

(6) Food Business Operator having valid certificate of an accredited food safety auditor or from an agencyaccredited by Food Authority or any other organisation authorised by food Authority for this purpose will not benormally required to be inspected before renewal of license.

Provided that Designated Officer may order an inspection before renewal if considered necessary for reasonsto be recorded in writing.

Regulation 3.2.8 Suspension or cancellation of Registration Certificate or license

(1) The Registering or Licensing Authority in accordance with the provisions of section 32 of the Act may,after giving the concerned Food Business Operator a reasonable opportunity of being heard, suspend any registrationor license in respect of all or any activities for which the registration/license has been granted under these Regulationsafter recording a brief statement of the reasons for such suspension, if there is ground to believe that the FoodBusiness Operator has failed to comply with the conditions and the period mentioned in any Improvement Noticeserved under Section 32 of the Act. A copy of such statement shall be furnished to the concerned Food BusinessOperator whose Registration or license has been suspended.

(2) The registering or licensing authority, as the case may be, shall direct an inspection of the Food BusinessOperator’s premise(s) within a reasonable period which shall not be less than 14 days from the date of order ofsuspension.

(3) In the event that the Registering or Licensing authority is of the opinion, on a review of the inspectionreport, that the Food Business Operator has still failed to rectify the defects or omissions or comply with theconditions of the improvement notice causing the suspension, such authority may cancel the license/registration ofthe Food Business Operator after giving him an opportunity to show cause as provided under Section 32 (3) of theAct.

(4) Notwithstanding anything contained in these Regulations, the Registering or Licensing Authority mayalso suspend or cancel any registration or license forthwith in the interest of public health for reasons to berecorded in writing.

(5) A suspension or cancellation of registration or license under these Regulations shall not entitle the FoodBusiness Operator for any compensation or refund of fee(s) paid in respect of the registration certificate or licenseor renewal thereof.

(6) The concerned Food Business Operator may make fresh application for inspection in case of suspensionand fresh application for Registration or license in case of cancellation to the concerned authority after takingnecessary precautions and making necessary changes or alterations after a minimum period of 3 months from thedate of cancellation under Regulation 3.2.8 (3) above.

Regulation 3.2.9 Modifications, Expansion or Changes in premise(s) after grant of license or registration

Food Business Operators shall ensure that the Registering or Licensing Authority always has up-to-dateinformation on their food business establishments and shall inform the relevant Authority of any modifications oradditions or changes in product category, layout, expansion, closure, or any other material information based onwhich the license was granted and such information shall be conveyed before the changes occur.

Provided that any change that alters the information contained in the license certificate shall require anapproval or endorsement in license prior to start of business with such changes. The Food Business Operator shallsubmit the original license to the Licensing Authority along with a fee equivalent to one year license fee for effectingnecessary changes. The Authority may approve and issue an amended license incorporating such changes inactivities within 30 days from the date of receipt of such information. While approving the aforementioned changesthe concerned registering or licensing Authority shall take into account the feasibility of carrying on the businessand the legal and other relevant aspects of the desired modifications or additions or changes in activities and, ifrequired, may order an inspection of the premises before granting the approval.

Page 7: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

416 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 3.2.10 Mode of payment:

All fees and charges payable under these regulations shall be paid vide pay order or demand draft or anyonline mode of payment as may be prescribed in this regard, by the concerned Food Safety Commissioner,

Regulation 3.2.11 Transfer of registration certificate or License in case of death

(1) In the event of death of the holder of a Registration certificate or license, such certificate or license shallsubsist for the benefit of the legal representative or any family member of the deceased or until the expiry of:—

(a) the period of 90 days from the date of death of the holder of a Registration certificate or license; or

(b) such longer period as the Designated Officer may allow, for reasons to be recorded in writing.

(2) The legal representative or family member of the deceased holder of the registration certificate or licenseshall apply to the concerned Authority for transfer of such certificate or license in his favour.

(3) The registering or licensing Authority, as the case may be, may, after making such enquiry as it may deemfit, either approve the transfer of the Registration certificate or license if satisfied that the applicant is the legalrepresentative, or refuse the request. Provided that the registering or licensing authority shall not refuse the requestwithout giving the applicant an opportunity of being heard and for reasons to be recorded in writing.

(4) Upon filing of application for transfer and pending the decision of the authority, the registration or licenseshall continue to be in force.

Regulation 3.2.12 Appeal

A Food Business Operator aggrieved by an order of the Registering Authority or Licensing Authority, as thecase may be, under these Regulations may prefer an appeal to the concerned Designated officer or the Food SafetyCommissioner, as per provisions laid down under Section 31(8) and 32 (4) - (5) of the Act.

Regulation 3.2.13 Return

(1) Every licensee shall on or before 31st May of each year, submit a return electronically or in physical form asmay be prescribed by the concerned Food Safety Commissioner, in ‘Form D-1’ provided in Schedule 2 of theseRegulations to the Licensing Authority in respect of each class of food products handled by him during theprevious financial year.

Provided however that Licensees engaged in manufacturing of milk and/or milk products shall file such returnin form D-2, Part-II as provided in Schedule-2 of these regulations.

Provided further that every licensee engaged in manufacturing milk and/or milk products shall also filemonthly return by 10th of every month for the previous month in the form D-2, Part I as provided in Schedule-2 ofthese regulations.

(2) A separate return shall be filed for every license issued under the Regulations, irrespective of whether thesame Food Business Operator holds more than one license.

(3) Any delay in filing return beyond 31st May of each year shall attract a penalty of Rs 100 per day of delay.

Regulation 3.2.14 Food Business Operator to be bound by directions or order

Every Food Business Operator to whom any direction or order is issued in pursuance of any provisions of thisorder shall be bound to comply with such directions or order and any failure on the part of the Food BusinessOperator to comply with such direction or order shall be deemed to be contravention of the provisions of theseRegulations and will attract legal action under the provisions of the Act.

Regulation 3.2.15 Power of Authority to constitute advisory committees

Notwithstanding anything contained in any of the regulations under the Act the Food Authority shall havepower to constitute advisory committees to assist, aid or advise on any matter concerning food safety or productspecific issues.

Page 8: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 417

SCHEDULE 1

List of food business falls under the purview of Central Licensing Authority

[See Regulation 3.2.2 (3)]

(1) Dairy units including milk chilling units equipped to handle or process more than 50,000 litres of liquid milk/dayor 2500 MT of milk solid per annum.

(2) Vegetable oil processing units and units producing vegetable oil by the process of solvent extraction andrefineries including oil expeller unit having installed capacity more than 2 MT per day.

(3) All slaughter houses equipped to slaughter more than 50 large animals or 150 or more small animals includingsheep and goats or 1000 or more poultry birds per day

(4) Meat processing units equipped to handle or process more than 500 kg of meat per day or 150 MT per annum

(5) All food processing units other than mentioned under (i) to (iv) including relabellers and repackers havinginstalled capacity more than 2 MT/day except grains, cereals and pulses milling units.

(6) 100 % Export Oriented Units

(7) All Importers importing food items for commercial use.

(8) All Food Business Operators manufacturing any article of Food which does not fall under any of the foodcategories prescribed under these regulations or deviates in any way from the prescribed specification for additivestherein.

(9) Retail chains operating in three or more states

(10) Food catering services in establishments and units under Central government Agencies like Railways, Air andairport, Seaport, Defence etc.

Page 9: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

418 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

SCHEDULE 2

Form ‘A’

Application for Registration / Renewal of Registration under Food Safety and Standards Act, 2006

[See Regulation 3.2.1 and Regulation 3.2.7 ]

Kind of business:

Itinerant / Mobile food vendor

Hawker

Home based canteens/dabba wallas

Petty Retailer of snacks/tea shops

Permanent/Temporary Stall holder

Manufacturer/Processor

Re Packer

Religious gatherings, food stalls in fairs etc

Milk producers (who are not member of dairy co operativesociety)/ milk vendor

Dhabha

Fish/meat/poultry shop/seller

Other(s), please specify:________

(a) Name of the Applicant/Company:

_______________________________________

(b) Designation or Capacity:

Individual

Partner

Proprietor

Secretary of co-operative society.

Others (Please specify)

(c) Proof of Identity of applicant:

_____________________________________

[Note: Please submit a copy of photo ID like Driving License, Passport, Ration Card or Election ID card]

(d) Correspondence address: _____________________________________________________________________

_________________________________________________________________________________________

Tel No:____________Mobile No.:____________

Fax No.:___________Email:________________________

[Note: In case the number(s) are a PP or common number(s), please specify the name of the contact person as well]

(e) Area or Location where food business is to be conducted/Address of the premises

___________________________________________________________________________________

(f) Description of the food items to be Manufactured or sold:

Photograph ofthe Applicant

Page 10: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 419

S.No. Name of Food category Description

Please attach separate sheet if required

(g) Total Annual turnover from the food business, if existing, alongwith any supporting document(s) showing proof ofincome (In case of renewal):

_________________________________________________________________________________________

(h) In case of new business - intended date of start:__________________

(i) In case of seasonal business, state the opening and closing period of the year:_______

(j) Source of water supply:

Public supply Private supply Any other source

(k) Whether any electric power is used in manufacture of the food items:

Yes

No

If yes, please state the exact HP used or sanctioned Electricity load: _______________

(l) I/We have forwarded a sum of Rs………towards registration fees according to the provision of the Food Safety andStandards (Licensing and Registration) Regulations, 2010 vide:

Demand Draft no......................... (payable to ————————)

Cash

(Signature of the Applicant)

Page 11: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

420 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Form ‘B’

Application for License / Renewal of license under Food Safety and Standards Act, 2006

[See Regulation 3.2.2, Regulation 3.2.3 & Regulation 3.2.7]

Kind of business (Please tick more than one, if applicable):

Manufacturing/Processing including sorting, grading etc.Milk Collection/chillingSlaughter HouseSolvent extracting unitSolvent extracting plant equipped with pre cleaning of oil seeds or pre expelling of oil.Solvent extracting and oil refining plant.PackagingRelabeling (manufactured by third party under own packing and labeling)ImportingStorage/Warehouse/Cold StorageRetail TradeWholesale TradeDistributor/SupplierTransporter of foodCateringDhabha or any other food vending establishmentClub /canteenHotelRestaurantOther(s), please specify:_____________________

1. Name of the Company: _______________________________________________________________________

_________________________________________________________________________________________

2. Registered Office Address: ____________________________________________________________________

_________________________________________________________________________________________

3. Address of Premise for which license is being applied ______________________________________________

_________________________________________________________________________________________

4. Name and/or designation qualification and address of technically qualified person in charge of operations asrequired under Regulation ____________________________________________________________________

Name:_________________________________________________________________________________

Qualification:___________________________________________________________________________

Address:_______________________________________________________________________________

Telephone Number(s):_________________________________________________________________

Mobile no: ______________________________________________

Email: ___________________________________________

Photo Identity card no and expiry date______________________________________________

Page 12: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 421

5. Name and/or designation, address and contact details of person responsible for complying with conditions oflicense (if different from 4 Above):

Name:_____________________________________________________________________________________

Address: __________________________________________________________________________________

Telephone Number(s): ___________________________________

Mobile no ____________________________________

Email: ____________________________

Photo Identity card no and expiry date

6. Correspondence address (if different from 3 above) ________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

7. TelNo.:____________Mobile No.:______________

Fax No:_______________ Email:___________________

8. Food items proposed to be manufactured:

S.No. Name of Food Item Description/ Installed production capacity

If required attach separate sheet

If already having valid license- mention annual quantity of each food category manufactured during last three years

9. Installed Capacity food product wise (per day)_____________________________________

10. For Dairy units

(i) Location and installed capacity of Milk Chilling Centers (MCC) / Bulk Milk Cooling Centers (BMCs) owned ormanaged by the applicant.

S.No. Name and address of MCC/BMC Installed Capacity

If required attach separate sheet

(ii) Average Quantity of milk per day to be used/handled in

(a) in lean season___________________________

(b) in flush season__________________________

11. For Solvent –Extracted Oil, De oiled meal and Edible Flour:

(i) Details of proposed business

Page 13: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

422 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Name of From seed Solvent –Extracted Oil, De oiled meal and Edible Flour VegetableOil bearing or nut or Oilmaterial cake

Crude Neutralized Neutralized & Refined De oiled meal Edible FlourBleached

If already having valid license- mention annual quantity of each product manufactured during last three years

(ii) Name and address of factory or factories used by the miller or solvent extractor for processing oil bearingmaterial produced or procured by him or for refining solvent extracted Oil produced by him.

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

12. Sanctioned electricity load or HP to be used ______________________________________________________

13. Whether unit is equipped with an analytical laboratory______________________________________________

If yes the details thereof: _____________________________________________________________________

14. In case of renewal or transfer of license granted under other laws as per proviso to Regulation 5(1) - period for whichlicense required ( 1 to 5 years) ____________

15. I/We have forwarded a sum of Rs.___________ towards License fees according to the provision of the Food Safetyand Standards (Licensing and Registration) Regulations, 2010 vide:

Demand Draft no.................................. (payable to ……………….)

(Signature of the Applicant/authorized signatory)

Page 14: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 423

Annexure I.

Declaration

I, Mr./Ms./Mrs. _________________ S/o / D/o Mr. ___________________,R/o ________________________do hereby solemnly affirm and declare that all information and particulars furnished here by me are true and correct to thebest of my knowledge. I further declare that the food business conducted or proposed to be conducted by/through meconforms/shall conform to the Food Safety and Standards Act, Regulations/ Bye-laws enacted thereunder, and specificallyto the Guidelines on Hygiene and Sanitary Practices provided under Schedule 4 of the Registration and LicensingRegulations published by the Food Safety and Standards Authority of India or any person authorized on its behalf fromtime to time.

Dated: (Signature)

Page 15: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

424 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Annexure-2

Documents to be enclosed with new application for license to State/Central Licensing Authority

1. Form-B duly completed and signed (in duplicate) by the proprietor/ partner or the authorised signatory

(2) Blueprint/layout plan of the processing unit showing the dimensions in metres/square metres and operation-wise area allocation.

(3) List of Directors with full address and contact details

(4) Name and List of Equipments and Machinery along with the number, installed capacity and horse power used.

(5) Photo I.D and address proof issued by Government authority of Proprietor/Partner/Director(s)/AuthorisedSignatory.

(6) List of food category desired to be manufactured. ( In case of manufacturers)

(7) Authority letter with name and address of responsible person nominated by the manufacturer along withalternative responsible person indicating the powers vested with them viz assisting the officers in inspections, collectionof samples, packing & dispatch.

(8) Analysis report (Chemical & Bacteriological) including pesticide residue of water to be used as ingredient in foodfrom a recognised/ public health laboratory to confirm the potability indicating the name of authorised representative ofLab who collected the sample and date of collecting sample

(9) Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill, etc.)

(10) Partnership Deed/Affidavit/Memorandum & Articles of Association towards the constitution of the firm.

(11) NOC from manufacturer in case of Re-labellers

(12) Food safety management system plan or certificate if any

(13) Source of milk or procurement plan for milk including location of milk collection centres etc in case of Milk andMilk Products processing units.

(14) Source of raw material for meat and meat processing plants

(15) Pesticide residues report of water to be used as ingredient in case of units manufacturing Packaged drinkingwater, packaged Mineral water and/or carbonated water from a recognised/ public health laboratory indicating the nameof authorised representative of Lab who collected the sample and date of collecting sample

(16) Recall plan, if any

(17) NOCs from Municipality or local body and from State Pollution Control Board except in case of notifiedindustrial area.

During renewal or transfer of license given under other laws existing prior to these Regulations

(1) Any change in documents or information provided during grant of previous license

(2) Certificate or Plan of Food Safety Management system being adopted (for units under Central Licensing it has tobe a certificate from accredited agencies)

(3) List of workers with their medical fitness certificates.

(4) Name, qualification and details of technical personnel in charge of operation.

Page 16: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 425

Annexure 3

Conditions of License

All Food Business Operators shall ensure that the following conditions are complied with at all times during thecourse of its food business.

Food Business Operators shall:

(1) Display a true copy of the license granted in Form C shall at all times at a prominent place in the premises

(2) Give necessary access to licensing authorities or their authorised personnel to the premises

(3) Inform Authorities about any change or modifications in activities

(4) Employ at least one technical person to supervise the production process. The person supervising the productionprocess shall possess at least a degree in Science with Chemistry/Bio Chemistry/Food and Nutrition/ Microbiology or adegree or diploma in food technology/ Dairy technology/ dairy microbiology/ dairy chemistry/ dairy engineering /oiltechnology /veterinary science /hotel management & catering technology or any degree or diploma in any other disciplinerelated to the specific requirements of the business from a recognized university or institute or equivalent.

(5) Furnish periodic annual return 1st April to 31st March, within 31st May of each year. For manufacture of Milk andMilk Products monthly returns also to be furnished.

(6) Ensure that no product other than the product indicated in the license/ registration is produced in the unit.

(7) Maintain factory’s sanitary and hygienic standards and worker’s Hygiene as specified in the Schedule – 4according to the category of food business.

(8) Maintain daily records of production, Raw materials utilization and sales in separate register. ( whichever isapplicable)

(9) Ensure that the source and standards of raw material used are of optimum quality.

(10) Food Business Operator shall not manufacture, store or expose for sale or permit the sale of any article of foodin any premises not effectively separated to the satisfaction of the licensing authority from any privy, urinal, sullage, drainor place of storage of foul and waste matter.

(11) Ensure Clean-In-Place systems (wherever necessary) for regular cleaning of the machine & equipments.

(12) Ensure testing of all relevant chemical and microbiological contaminants in food products through own orNABL/FSSA recognized labs atleast once in a month.

(13) Ensure that required temperature is maintained throughout the supply chain from the place of procurement orsourcing till it reaches the end consumer including chilling, transportation, storage etc.

Other conditions

(1) Proprietors of hotels, restaurants and other food stalls who sell or expose for sale savouries, sweets or otherarticles of food shall put up a notice board containing separate lists of the articles which have been cooked in ghee, edibleoil, vanaspati and other fats for the information of the intending purchasers.

(2) Food Business Operator selling cooked or prepared food shall display a notice board containing the nature ofarticles being exposed for sale

(3) Every manufacturer [including ghani operator] or wholesale dealer in butter, ghee, vanaspati, edible oils, Solventextracted oil, de oiled meal, edible flour and any other fats shall maintain a register showing the quantity of manufactured,received or sold, nature of oil seed used and quantity, quantity of de oiled meal and edible flour used etc. as applicable andthe destination of each consignment of the substances sent out from his manufactory or place of business, and shallpresent such register for inspection whenever required to do so by the licensing authority.

(4) No producer or manufacturer of vegetable oil, edible oil and their products shall be eligible for license under thisAct, unless he has his own laboratory facility for analytical testing of samples.

Page 17: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

426 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(5) Every sale or movement of stocks of solvent-extracted oil, ‘semi refined’ or ‘raw grade I’, edible groundnut flouror edible coconut flour, or both by the producer shall be a sale or movement of stocks directly to a registered user and notto any other person, and no such sale or movement shall be effected through any third party.

(6) Every quantity of solvent-extracted oil, edible groundnut flour or edible coconut flour, or both purchased by aregistered user shall be used by him in his own factory entirely for the purpose intended and shall not be re-sold orotherwise transferred to any other person:

Provided that nothing in this sub-clause shall apply to the sale or movement of the following:—

(i) karanjia oil;

(ii) kusum oil;

(iii) mahuva oil;

(iv) neem oil;

(v) tamarind seed oil;

(vi) edible groundnut flour bearing the I.S.I.Certification Mark; and

(vii) edible coconut flour bearing the I.S.I.Certification Mark.

(7) No Food Business Operator shall sale or distribute or offer for sale or dispatch or deliver to any person forpurpose of sell any edible oil which is not packed, marked and labelled in the manner specified in the regulations unlessspecifically exempted from this condition vide notification in the official Gazette issued in the public interest by FoodSafety Commissioners in specific circumstances and for a specific period and for reasons to be recorded in writing.

Page 18: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 427

FORM ‘C’ - License Format

[See Regulation 3.2.4 (6)]

Government of India

Food Safety and Standards Authority of India

License under FSS Act, 2006

License No _________________

1. Name and Registered Office address of licensee

_________________________________________________________________________________________

2. Address of authorized premises ________________________________________________________________

3. Kind of Business____________________________________________________________________________

4. For dairy business details of location with address and capacity of Milk Chilling Centers (MCC) / Bulk Milk CoolingCenters (BMCs) owned by the holder of licensee/RC

5. Category of License:

This license is granted under and is subject to the provisions of FSS Act, 2006 all of which must be complied with bythe licensee.

Place:

Date:

Stamp and signature of Designated Officer

Food Safety and Standards Authority of India

Validation and Renewal

Renewal Period of License fee Items of Food products with capacities authorized Signature ofDate validity paid to Manufacture/ Re-pack/ Re-label Designated

Officer

Page 19: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

428 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

‘FORM D-1’

Annual Return

(for business other than milk and milk products)

(See Regulation 3.2.13)

1. Name and address of Licensee:______________________________________________________________

2. Address of the authorized premises for the manufacturing / re-packing / re-labelling of food products: _______

______________________________________________________________________________________

3. License No. _____________________

4. Statement showing quantities of food products manufactured and exported in Tonnes

Name of Size of can/ Quantity in Sale price Value Quantity Name of the Rate per Kg Value Remarksthe food bottle/any MT per Kg exported/ country or or per unitproduct other package or per imported port of of packing

(like PP) unit of in Kg Export C.I.F. /F.O.Bor bulk packingpackage

1 2 3 4 5 6 7 8 9 10

Page 20: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 429

‘FORM D-2’

(See Regulation 3.2.13)

Part I

Monthly Return for Milk and Milk Products

For the month …………….. of the year ………..

1. Name and address of Licensee:_______________________________________________________________

2. Address of the authorized premises for the manufacturing/re-packing/re-labelling of food products:

3. License No. ______________________

4. Milk Procurement

Type Total Av. Price Price Price Remarks, if anyof Qty. Rs/kg Rs./kg Rs./kgmilk (Tonnes) of milk of fat of SNF

Cow

Buffalo

Mixed

Rs/kg - Rupees per kilogramme

5. Details of Receipts, Sale and Stocks of Products

Product Opening Receipts Product ClosingName stock Produced Purchased sold stock(tonnes) (tonnes) (tonnes) (tonnes) (tonnes)

1. Fresh milk• Standardized• Toned• Double toned

• Whole• Skimmed• Others (Specify)

2. Milk fat products• Butter• Ghee• Butteroil

3. Dried milks• Skimmed• Whole

4. Other milk products

Place

Date Signature of the Licensee

A register detailing the above information shall be maintained by each licensee for inspections.

Page 21: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

430 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

‘Form D-2’

Part II

Annual Return for Milk and Milk Products

For the year …….

1. Name and address of Licensee:______________________________________________________________

2. Address of the authorized premises for the manufacturing/re-packing/re-labelling of food products: ________________________________________________________________________________________________

3. License No. _______________________

4. Statement showing quantities of food products manufactured and exported in Tonnes with their sale value duringthe period _________________________________

Procurement

Type of milk Total Qty MT Procurement Total SNF MT Price Rs / Price Rs/kg Price Rs/kgTotal fat MT kg of milk of fat of SNF

1 2 3 4 5 6 7

Cow

Buffalo

Mixed

Products

Reconstitution

Utilized for making liquid milk Whole milk powder Skimmed milk Butter oil (tonne) White butter (tonne)or milk products (tonne) powder (tonne)

All liquid milks for sale

• In lean season (Apr-Sep)

• In flush season (Oct-Mar)

Other milk products

• In lean season (Apr-Sep)

• In flush season (Oct-Mar)

Annexure details regarding name, location etc.

Page 22: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 431

Stocks

Product Opening stock Closing stockName (Tonnes) (Tonnes)

1. Fresh milk

• Standardized

• Toned

• Double toned

• Whole

• Skimmed

• Others (Specify)

2. Milkfat products

• Butter

• Ghee

• Butteroil

3. Dried milks

• Skimmed

• Whole

4. Other milk products

Date: Signature of the Licensee

A register detailing the above information shall be maintained by each licensee for inspections.

.

Page 23: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

432 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

SCHEDULE - 3

Fee for Grant/ Renewal of Licence

Registration / Licence Fee Per Annum in Rupees

1. Fees for Registration Rs 100

2. Fees for License issued by Central

Licensing Authority: Rs 7500

3. Fees for License issued by State Licensing Authority:

1. Manufacturer /Miller

(i) Above 1MT per day Production or 10,001 to 50,000 LPD of milk or 501 to 2500 MTof milk solids per annum Rs. 5000/—

(ii) Below 1 MT of Production or 101 to 10,000 LPD of milk or 51 MT to 500 MT of milksolids per annum Rs.3000/—

2. Hotels –3 Star and above Rs. 5000/—

3. All Food Service providers including restaurants/boarding houses, clubs etc.serving food, Canteens (Schools, Colleges, Office, Institutions), Caterers, Banquet hallswith food catering arrangements, food vendors like dabba wallas etc. Rs. 2000/—

4. Any other Food Business Operator Rs. 2000/—

The fees paid by any applicant for a licence shall not be refundable under any circumstances.

Issue of Duplicate registration or License

(1) Where a registration certificate or license is lost, destroyed, torn, defaced or mutilated, the applicant mayapply for a duplicate copy of the registration certificate or license during the validity period, accompaniedwith a fee amounting to 10% of the applicable License fee.

(2) On receipt of such an application, the Licensing Authority shall grant a duplicate copy of the registrationcertificate or license, as the case may be to the applicant with the word “Duplicate” appearing prominentlythereon.

Page 24: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 433

Schedule 4

General Hygienic and Sanitary practices to be followed by Food Business operators

It is hereby recognized and declared as a matter of legislative determination that in the field of human nutrition, safe,clean, wholesome food for manufacturing purposes is indispensable to the health and welfare of the consumer of thecountry; that majorly food is a perishable commodity susceptible to contamination and adulteration; that the productionand distribution of an adequate supply of clean, safe and wholesome food for processing, manufacturing and directconsumption purposes are significant to sound health and that minimum sanitary and hygienic conditions are deemed tobe necessary for the production and distribution of milk for manufacturing purposes.

The establishment in which food is being handled, processed, manufactured, stored, distributed by the foodbusiness operator whether holder of registration certificate or a license as per the norms laid down in these regulationsand the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and otherstandard as specified below. It shall also be deemed to be the responsibility of the food business operator to ensureadherence to necessary requirements.

In case inspection of the units is directed by the Registering or Licensing Authority, the inspection should confirmthat the following measures are adopted by the unit as far as possible:

Part I - General Hygienic and Sanitary practices to be followed by Petty Food Business Operators applying for Registration

[See Regulation 3.2.1(2)]

A. SANITARY AND HYGIENIC REQUIREMENTS FOR FOOD MANUFACTURER/ PROCESSOR

The place where food products are manufactured, shall comply with the following requirements:

(1) The premises to conduct food business for manufacturing should not have area less than 20 m2 andadequate space for storage.

(2) The premises shall be clean, adequately lighted and ventilated and sufficient free space for movement.

(3) The premises shall be located in a sanitary place and free from filthy surroundings.

(4) Floors and walls must be maintained in a sound condition. They should be smooth and easy to clean.

(5) Ceilings should be in good condition, smooth and easy to clean, with no flaking paint or plaster.

(6) The floor and skirted walls shall be washed daily with a disinfectant like phenyl at the close of day’sbusiness.

(7) The premises shall be kept free from all insects by an insecticidal spray having knock-down effect at theclose of day’s business. No spraying shall be done during the conduct of business, but instead fly swats/ flapsshould be used to kill spray flies getting into the premises. Windows, doors and other opening suited to screeningshall be fly proofed.

(8) The water used in the manufacturing shall be potable and if required chemical and bacteriological examinationof the water shall be done at regular intervals at any recognized laboratory.

(9) Continuous supply of potable water shall be ensured in the premises. In case of intermittent water supply,adequate storage arrangement shall be made.

(10) Equipment and machinery when employed shall be of such design which will permit easy cleaning.Arrangements for cleaning of containers, tables, working parts of machinery, etc. shall be provided.

(11) Packaging material employed in the preparation, packing or storage of food should be in appropriatemanner, clean and hygienic.

(12) All equipments shall be kept clean, washed, dried and stacked at the close of day’s business to ensurefreedom from growth of mould/ fungi and infestation. All equipments shall be placed well away from the walls toallow proper inspection.

(13) There should be efficient drainage system and there shall be provisions for disposal of refuse.

(14) The workers working in processing and preparation shall use clean aprons, hand gloves, and head wears.

Page 25: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

434 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(15) Persons suffering from infectious diseases shall not be permitted to work. Any cuts or wounds shallremain covered at all time and the person should not be allowed to come in direct contact to food.

(16) All food handlers shall keep their finger nails trimmed, clean and wash their hands with soap, detergentand water before commencing work and every time after using toilet.

(17) Scratching of body parts, hair shall be avoided during food handling processes.

(18) All food handlers should avoid wearing jewellery, false nails or other items that might fall into food andalso avoid touching their face or hairs.

(19) Eating, chewing, smoking, spitting and nose blowing shall be prohibited within the premises.

(20) All articles that are stored or are intended for sale shall have proper cover to avoid contamination.

(21) The vehicles used to transport foods must be maintained in good repair and kept clean.

(22) Foods while in transport in packaged form or in containers shall maintain the required temperature.

(23) Insecticides / disinfectants shall be kept and stored separately and ‘away from food manufacturing /storing / handling areas.

B. Sanitary and Hygienic Requirements for Units other than Manufacturing

(1) Location shall be away from rubbish, waste water, toilet facilities, open drains and animals.

(2) Rubbish bin with cover shall be provided.

(3) Working surfaces of vending carts shall be hygienic, impermeable, easy to clean (like stainless steel), 60 to70 cm. from ground.

(4) Sale points, tables, awnings, benches and boxes, cupboards, glass cases, etc. shall be clean and tidy.

(5) Cooking utensils and crockery shall be clean and in good condition. It should not be broken/ chipped.

(6) All containers shall be kept clean, washed and dried at the close of day’s business to ensure freedom fromgrowth of mould/ fungi and infestation.

(7) Vending cart shall be built of solid, rust/ corrosion resistant materials and kept in clean and good condition.

(8) Transported drinking water (treated water like bottled water, boiled/ filtered water through water purifieretc.) shall be in protected containers of at least 20 litres.

(9) Vending cart shall be protected from sun, wind and dust and when not in use, food vending vans shall bekept in clean place and properly protected.

(10) Cooking, storage and serving shall not be done in utensils of copper, cadmium, lead, non food gradeplastic and other toxic materials.

(11) Utensils shall be cleaned of debris, rinsed, scrubbed with detergent and washed under running tap waterafter every operation.

(12) Wiping utensils shall be done with clean cloth.

(13) Removing dust or crumb shall not be done by blowing on the plates or utensils.

(14) The person suffering from infectious disease shall not be permitted to work.

(15) All food handlers shall keep their finger nails trimmed, clean and wash their hands with soap, detergentand water before commencing work and every time after using toilet.

(16) All food handlers should avoid wearing jewellery, false nails or other items that might fall into food andalso avoid touching their face or hairs.

(17) All articles that are stored or intended for sale shall have proper cover to avoid contamination.

(18) Eating, chewing, smoking, sniffing, spitting and nose blowing shall be prohibited within the premises.

(19) Adequate number of racks, shall be provided for storage of articles of food, with clear identity of eachcommodity. Proper compartment for each class shall also be provided wherever possible.

Page 26: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 435

Part-II

General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators

The establishment in which food is being handled, processed, manufactured, packed, stored, and distributed by thefood business operator and the persons handling them should conform to the sanitary and hygienic requirement, foodsafety measures and other standard as specified below. It shall also be deemed to be the responsibility of the foodbusiness operator to ensure adherence to necessary requirements.

In addition to the requirements specified below, the food business shall identify steps in the activities of foodbusiness, which are critical to ensuring food safety, and ensure that safety procedures are identified, implemented,maintained and reviewed periodically.

1. Location and Surroundings

1.1 Food Establishment shall be located away from environmentally polluted areas and industrial activities whichproduce disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemical or biological emissions andpollutants, and which pose a serious threat of contaminating food; areas subject to flooding; areas prone to infestationsof pests; and areas where wastes, either solid or liquid, cannot be removed effectively.

1.2 The premise should not be used for residential purpose, nor shall it has or capable of having direct access insidethe premise.

2. Layout and Design of Food Establishment Premises

2.1 The layout of the food establishment shall be such that food preparation / manufacturing process are not subjectto cross-contamination from viz. receiving, pre-processing (viz. packaging, dishing / portioning of ready-to-eat food) Toprevent cross contamination, the activities shall be totally compartmentalized and strict measures should be taken to seethat material movement happens only in one direction without any backward flow and any mixing up of various activities.Area occupied by machinery shall not be more than 50% of the manufacturing area.

2.2 The floor of food processing / food service area shall be made of impervious, non-absorbent, washable and non-toxic materials. Floor surfaces shall remain dry and maintained in a sound condition so that they are easy to clean andwhere necessary, disinfect. Floors shall be sloped appropriately to facilitate drainage and the drainage shall flow in adirection opposite to the direction of food preparation / manufacturing process flow. The openings of the drains to bethoroughly covered with wire mesh to prevent insects and rodents from entering the processing area.

2.3 The walls shall be made of impervious, non-absorbent, washable and non-toxic materials and require a smoothsurface easy to clean up to a height appropriate for the operations and wherever necessary, disinfect.

2.4 Ceilings and overhead fixtures shall be designed, constructed, finished and maintained so as to minimize theaccumulation of dirt, condensation and growth of undesirable moulds and shedding of paint or plaster particles. Sufficientnumber of Windows and exhaust openings shall be provided to minimize accumulation of dirt.

2.5 Windows, doors & all other openings to outside environment shall be well screened with wire-mesh or insect-proof screen as applicable to protect the premise from fly and other insects / pests / animals & the doors be fitted withautomatic closing springs. The mesh or the screen should be type which can be easily removed for cleaning.

2.6 Doors shall be made of smooth and non-absorbent surfaces so that they are easy to clean and wherevernecessary, disinfect.

3. Equipment

3.1 Equipment and containers that come in contact with food and used for food handling, storage, preparation,processing, packaging and serving shall be made of corrosion free materials, which do not impart any toxicity to the foodmaterial. Equipment and utensils used in the preparation of food shall be kept at all times in good order and repair and ina clean and sanitary condition. No such utensil or container shall be used for any other purpose.

3.2 Every utensil or container containing any food or ingredient of food intended for sale shall at all times be eitherprovided with a proper fitting cover/lid or with a clean gauze net or other material of texture sufficiently fine to protect thefood completely from dust, dirt and flies and other insects.

3.3 No utensil or container used for the manufacture or preparation of or containing any food or ingredient of foodintended for sale shall be kept in any place in which such utensil or container is likely by reason of impure air or dust or any

Page 27: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

436 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

offensive, noxious or deleterious gas or substance or any noxious or injurious emanations, exhalation, or effluvium, to becontaminated and thereby render the food noxious.

3 Equipment shall be such located, designed and fabricated so that it permits necessary maintenance and cleaningfunctions as per its intended use and facilitates good hygiene practices inside the premise including monitoring and audit.

3.4 Appropriate facilities for the cleaning and disinfecting of equipments and instruments especially cleaning inplace (CIP) system to be adopted.

3.5 Equipment and containers for waste, by-products and inedible or dangerous substances, shall be specificallyidentifiable and suitably constructed.

3.6 Containers used to hold cleaning chemicals and other dangerous substances shall be identified and storedseparately to prevent malicious or accidental contamination of food.

3.7 To put in place, if required, a waste water disposal system / effluent treatment plant as approved by StatePollution Control Board

3.8 All items, fittings and equipment that touch or come in contact to food must be:

(i) kept in good condition in a way that enables them to be kept clean and wherever necessary, to be disinfected

(ii) Chipped enameled containers will not be used. Stainless /aluminum / glass containers, mugs, jugs, traysetc. suitable for cooking and storing shall be used. Brass utensils shall be frequently provided with in lining

4. Facilities

4.1 Water supply

4.1.1 Only potable water, meeting the requirements of Bureau of Indian Standards specifications, with appropriatefacilities for its storage, distribution shall be used as an ingredient and also for food handling, washing, processingand cooking. Water storage tanks shall be cleaned periodically and records of the same shall be maintained in aregister.

4.1.2 Non potable water can be used provided it is intended only for cooling of equipment, steam production,fire fighting & refrigeration equipment and provided that pipes installed for this purpose preclude the use of thiswater for other purposes and present no direct or indirect risk of contamination of the raw material, dairy productsor food products so processed, packed & kept in the premise.

4.1.3 Non potable water pipes shall be clearly distinguished from those in use for potable water.

4.2 For Cleaning Utensils / Equipments

Adequate facilities for cleaning, disinfecting of utensils and equipments shall be provided. The facilities musthave an adequate supply of hot and cold water.

4.3 Washing of Raw materials

Adequate facilities for washing of raw food should be provided. Every sink (or other facilities) for washingfood must have an adequate supply of hot and/or cold water. The water shall at least be of potable in nature. Thesefacilities must be kept clean and, where necessary, disinfected. Sinks which are used for washing raw foods shall bekept separate and that should not be used for washing utensils or any other purposes.

4.4 Ice and Steam

Ice and steam used in direct contact with food shall be made form potable water and shall comply withrequirements specified under 4.1.1. Ice and steam shall be produced, handled and stored in such a manner that nocontamination can happen

4.5 Drainage and waste disposal

4.5.1 The disposal of sewage and effluents (solid, liquid and gas) shall be in conformity with requirements ofFactory/ Environment Pollution Control Board. Adequate drainage, waste disposal systems and facilities shall beprovided and they shall be designed and constructed in such manner so that the risk of contaminating food or thepotable water supply is eliminated.

Page 28: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 437

4.5.2 Waste storage shall be located in such that it does not contaminate the food process, storage areas, theenvironment inside and outside the food establishment and waste shall be kept in covered containers and shall notbe allowed to accumulate in food handling, food storage, and other working areas.

4.5.3 Periodic disposal of the refuse / waste be made compulsory. No waste shall be kept open inside thepremise and shall not be discharged outside the premise, on the road or drainage system.

4.5.4 Proper care shall be taken while disposing plastic /metal / glass materials, bags, containers and otherswhich are not environment friendly.

4.5.5 Food waste and other waste materials shall be removed periodically from the place where food is beinghandled or cooked or manufactured to avoid building up. A refuse bin of adequate size with a pedal operated covershall be provided in the premises for collection of waste material. This shall be emptied and washed daily with adisinfectant and dried before next use.

4.6 Personnel facilities and toilets

4.6.1 Personnel facilities shall include proper washing and drying of hands before touching food materialsincluding wash basins and a supply of hot and /or cold water as appropriate; separate lavatories, of appropriatehygienic design, for males and females separately; and changing facilities for personnel and such facilities shall besuitably located so that they do not open directly into food processing, handling or storage areas.

4.6.2 Number of toilets depends on the number of employees (male /female) in the establishment and theyshould be made aware of the cleanliness requirement while handling food.

4.6.3 Rest and refreshments rooms shall be separate from food process and service areas and these areas shallnot lead directly to food production, service and storage areas.

4.6.4 A display board mentioning do’s & don’ts for the workers shall be put up inside a prominent place in thepremise in English or in local language for everyone’s understanding

4.7 Air quality and ventilation

Ventilation systems natural and /or mechanical including air filters, exhaust fans, wherever required, shall bedesigned and constructed so that air does not flow from contaminated areas to clean areas.

4.8 Lighting

Natural or artificial lighting shall be provided to the food establishment, to enable the undertaking to operatein a hygienic manner. Lighting fixtures must wherever appropriate, be protected to ensure that food is not contaminatedby breakages.

5. Food Operations and Controls

5.1 Procurement of raw materials

5.1.1 No raw material or ingredient thereof shall be accepted by an establishment if it is known to containparasites, undesirable micro-organisms, pesticides, veterinary drugs or toxic items, decomposed or extraneoussubstances, which would not be reduced to an acceptable level by normal sorting and/or processing.

5.1.2 In addition the raw materials, food additives and ingredients, wherever applicable, shall conform to theRegulations and regulations laid down under the Act.

5.1.3 Records of raw materials, food additives and ingredients as well as their source of procurement shall bemaintained in a register for inspection.

5.2 Storage of raw materials and food5.2.1 Food storage facilities shall be designed and constructed to enable food to be effectively protected from

contamination during storage; permit adequate maintenance and cleaning, to avoid pest access and accumulation.5.2.2 Cold Storage facility shall be provided to raw processed / packed food according to the type and

requirement.5.2.3 Segregation shall be provided for the storage of raw, processed, rejected, recalled or returned materials

or products. Such areas, materials or products shall be suitable if marked and secured. Raw materials and food shallbe stored in separate areas from printed packaging materials, stationary, hardware and cleaning materials / chemicals.

Page 29: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

438 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

5.2.4 Raw food, particularly meat, poultry and seafood products shall be cold stored separately from the areaof work-in-progress, processed, cooked and packaged products. The conditions of storage in terms of temperatureand humidity requisite for enhancing the shelf life of the respective food materials / products shall be maintained.

5.2.5 Storage of raw materials. Ingredients, work-in-progress and processed / cooked or packaged foodproducts shall be subject to FIFO (First in, First Out) stock rotation system.

5.2.6 Containers made of non-toxic materials shall be provided for storage of raw materials, work-in-progressand finished / ready to serve products. The food materials shall be stored on racks / pallets such that they arereasonably well above the floor level and away from the wall so as to facilitate effective cleaning and preventharbouring of any pests, insects or rodents.

5.3 Food Processing / Preparation, Packaging and Distribution / Service

5.3.1.Time and temperature control

5.3.1.1 The Food Business shall develop and maintain the systems to ensure that time and temperatureis controlled effectively where it is critical to the safety and suitability of food. Such control shall include timeand temperature of receiving, processing, cooking, cooling, storage, packaging, distribution and food serviceupto the consumer, as applicable.

5.3.1.2 Whenever frozen food / raw materials are being used / handled / transported, proper care shouldbe taken so that defrosted / thawed material shall not be stored back and after opening for future use.

5.3.1.3 Such systems shall also specify tolerance limits for time and temperature variations and therecords thereof shall be maintained in a register for inspection.

5.3.1.4 Wherever cooking is done on open fire, proper outlets for smoke/steam etc. like chimney, exhaustfan etc. shall be provided.

5.4 Food Packaging

5.4.1 Packaging materials shall provide protection for all food products to prevent contamination, damage andshall accommodate required labelling as laid down under the FSS Act & the Regulations there under.

5.4.2 Only Food grade packaging materials to be used. For packaging materials like aluminium plastic and tin,the standards to be followed are as mentioned under the FSS Regulations and rules framed there under.

5.4.3 Packaging materials or gases where used, shall be non-toxic and shall not pose a threat to the safety andsuitability of food under the specified conditions of storage and use.

5.5 Food Distribution / Service

5.5.1 An appropriate supply chain needs to be incorporated in the system to minimize food spoilage duringtransportation Processed / packaged and / or ready-to-eat food shall be protected during transportation and / orservice.

5.5.2 Temperatures and humidity which is necessary for sustaining food safety and quality shall be maintained.The conveyances and /or containers shall be designed, constructed and maintained in such that they can effectivelymaintain the requisite temperature, humidity, atmosphere and other conditions necessary to protect food Conveyancesand / or containers used for transporting / serving foodstuffs shall be non toxic, kept clean and maintained in goodcondition in order to protect foodstuffs from any contamination.

5.5.3 Receptacles in vehicles and / or containers shall not be used for transporting anything other thanfoodstuffs where this may result in contamination of foodstuffs. Where the same conveyance or container is usedfor transportation of different foods, or high risk foods such as fish, meat, poultry, eggs etc., effective cleaning anddisinfections shall be carried out between loads to avoid the risk of cross- contamination. For bulk transport of food,containers and conveyances shall be designated and marked for food use only and be used only for that purpose.

6. Management and Supervision

6.1 A detailed Standard Operating Procedure (SOP) to be developed for proper management which in turn wouldhelp in identifying any problem at exact point, so the course of damage control would be faster

Page 30: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 439

6.2 The Food Business shall ensure that technical managers and supervisors have appropriate qualifications,knowledge and skills on food hygiene principles and practices to be able which shall enable them to ensure food safetyand quality of its products, judge food hazards, take appropriate preventive and corrective action, and to ensure effectivemonitoring and supervision.

7. Food Testing Facilities

7.1 A well equipped, modern laboratory for testing of food materials / food for physical, microbiological and chemicalanalysis in accordance with the specification/standards laid down under the rules and regulations shall be in place insidethe premise for regular / periodic testing and when ever required.

7.2 In case of any suspicion or possible contamination, food materials / food shall be tested before dispatch from thefactory.

7.3 If there is no in house laboratory facility, then regular testing shall be done through an accredited laboratory. Incase of complaints received and if so required, the company shall voluntarily do the testing either in the in-houselaboratory or from a designated lab outside.

8. Audit, Documentation and Records

8.1 A periodic audit of the whole system according to the SOP be done to find out any fault / gap in the GMP / GHPsystem

8.2 Appropriate records of food processing / preparation, production / cooking, storage, distribution, service, foodquality, laboratory test results, cleaning and sanitation, pest control and product recall shall be kept and retained for aperiod of one year or the shelf-life of the product, whichever is more.

9. Sanitation and Maintenance of Establishment Premises

9.1 Cleaning and maintenance

9.1.1 A cleaning and sanitation programme shall be drawn up and observed and the record thereof shall beproperly maintained, which shall indicate specific areas to be cleaned; and cleaning frequency; cleaning procedureto be followed, including equipment and materials to be used for cleaning. Equipments used in manufacturing to becleaned and sterilized after each use at the end of the day.

9.1.2 Cleaning chemicals shall be handled and used carefully in accordance with the instructions of themanufacturer and shall be stored separately away from food materials, in clearly identified containers, to avoid anyrisk of contaminating food.

9.1.3 Preventive maintenance of equipment, machinery, building and other facilities shall be carried out regularlyas per the instructions of the manufacturer, to prevent any hazards from entering into the food while being processedor packed or served. Non-toxic, edible grade lubricants shall be used.

9.2 Pest Control Systems

9.2.1 Food establishment shall be kept in good repairing condition to prevent pest access and to eliminatepotential breeding sites. Holes, drains and other places where pests are likely to gain access shall be kept in sealedcondition or fitted with mesh / grills / claddings as required and animals, birds and pets shall not be allowed to enterinto the food establishment areas/ premises.

9.2.2 Food materials shall be stored in pest-proof containers stacked above the ground and away from walls.

9.2.3 Pest infestations shall be dealt with immediately and without adversely affecting the food safety orsuitability. Treatment with permissible chemical, physical or biological agents, within the permissible limits, shall becarried out without posing a threat to the safety or suitability of food. Records of pesticides / insecticides usedalong with dates and frequency shall be maintained.

10. Personal Hygiene

10.1 Health Status

10.1.1 Personnel known, or suspected, to be suffering from, or to be a carrier of a disease or illness likely to betransmitted through food, shall not be allowed to enter into any food handling area if there is a likelihood of their

Page 31: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

440 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

contaminating food. The Food Business shall develop system, whereby any person so affected, shall immediatelyreport illness or symptoms of illness to the management and medical examination of a food handler shall be carriedout apart from the periodic checkups, if clinically or epidemiologically indicated.

10.1.2 Arrangements shall be made to get the food handlers / employees of the establishment medicallyexamined once in a year to ensure that they are free from any infectious, contagious and other communicablediseases. A record of these examinations signed by a registered medical practitioner shall be maintained for inspectionpurpose.

10.1.3 The factory staff shall be compulsorily inoculated against the enteric group of diseases once a year anda record towards that shall be kept for inspection.

10.1.4 In case of an epidemic, all workers to be vaccinated irrespective of the yearly vaccination.

10.2 Personal Cleanliness

10.2.1 Food handlers shall maintain a high degree of personal cleanliness. The food business shall provide toall food handlers with adequate and suitable clean protective clothing, head covering, face musk, gloves andfootwear and the food business shall ensure that the food handlers at work wear only clean protective clothes, headcovering and footwear every day.

10.2.2 Food handlers, with any cut or wounds in their person, shall not come in direct contact with food orfood contact surfaces.

10.2.3 Food handlers shall always wash their hands with soap and clean potable water, disinfect their handsand then dry with hand drier or clean cloth towel or disposable paper at the beginning of food handling activities;immediately after using the toilet; and after handling raw food or any contaminated material, tools, equipment orwork surface, where this could result in contamination of other food items.

10.3 Personal Behavior

10.3.1 Food handlers engaged in food handling activities shall refrain themselves from smoking; spitting;chewing or eating; sneezing or coughing over any food whether protected or unprotected food and eating in foodpreparation and food service areas.

10.3.2 The food handlers should trim their nails and hair periodically, do not encourage or practice unhygienicmeans while handling food.

10.3.3 Persons working directly with and handling raw materials or food products shall maintain high standardsof personal cleanliness at all times. In particular:

(a) they shall not smoke, spit, eat or drink in areas or rooms where raw materials and food products arehandled or stored;

(b) wash their hands at least each time work is resumed and whenever contamination of their hands hasoccurred; e.g. after coughing / sneezing, visiting toilet, using telephone, smoking etc.

(c) avoid certain hand habits - e.g. scratching nose, running finger through hair, rubbing eyes, ears andmouth, scratching beard, scratching parts of bodies etc.- that are potentially hazardous when associated withhandling food products, and might lead to food contamination through the transfer of bacteria from theemployee to product during its preparation. When unavoidable, hands should be effectively washed beforeresuming work after such actions.

10.3.4 Food handlers shall not wear any belonging such as rings, bangles, jewellery, watches, pins and otheritems that pose a threat to the safety and suitability of food.

10.4 Visitors

10.4.1 Generally visitors should be discouraged to go inside the food handling areas. However, proper carehas to be taken to ensure that food safety & hygiene is not getting compromised due to visitors in the floor area.

10.4.2 The Food Business shall ensure that visitors to its food manufacturing, cooking, preparation, storageor handling areas must wherever appropriate, wear protective clothing, footwear and adhere to the other personalhygiene provisions envisaged in this section.

Page 32: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 441

11. Product Information and Consumer Awarness

All packaged food products shall carry a label and requisite information shall be there as per provisions of FoodSafety & Standards Act, 2006 and Regulations & Regulations made there under so as to ensure that adequate andaccessible information is available to the next person in the food chain to enable them to handle, store, process, prepareand display the food products safely and correctly and that the lot or batch can be easily traced and recalled if necessary.

12. Training

12.1 The Food Business shall ensure that all food handlers are aware of their role and responsibility in protectingfood from contamination or deterioration. Food handlers shall have the necessary knowledge and skills which are relevantto the food processing / manufacturing, packing, storing and serving so as to ensure the food safety and food quality.

12.2 The Food Business shall ensure that all the food handlers are instructed and trained in food hygiene and foodsafety aspects along with personal hygiene requirements commensurate with their work activities, the nature of food, itshandling, processing, preparation, packaging, storage, service and distribution.

12.3 Periodic assessments of the effectiveness of training shall be made, as well as routine supervision and checksto ensure that food hygiene and food safety procedures are being carried out effectively Training programme shall beroutinely reviewed and updated wherever necessary.

Part-III

Specific Hygienic and Sanitary Practices to be followed by Food Business Operators engaged in manufacture,processing, storing & selling of Milk and Milk Products

In addition to Part-2, the dairy establishment in which dairy based food is being handled, processed, manufactured,stored, distributed and ultimately sold by the food business operator, and the persons handling them should conform tothe sanitary and hygienic requirement, food safety measures and other standard as specified below.

I. Sanitary Requirements

1.1 Dairy Establishments shall have the following:

(a) facilities for the hygienic handling and protection of raw materials and of non-packed or non-wrappeddairy products during loading and unloading, transport & storing including Bulk Milk cooling facilities

(b) appropriate arrangements for protection against pests is must;

(c) instruments and working equipment intended to come into direct contact with raw materials and dairyproducts which are made of corrosion-resistant material and which are easy to clean and disinfect;

(d) special watertight, non-corrodible containers in which to put raw materials or dairy products intended forhuman consumption. Where such raw materials or dairy products are removed through conduits, these shall beconstructed and installed in such a way so as to avoid any risk of contamination of other raw materials or dairyproducts;

(e) appropriate facilities for the cleaning and disinfecting of equipment and instruments especially cleaning inplace (CIP) system;

(f) an waste water disposal system which is hygienic and approved by Pollution Control Board;

(g) a lockable room or a secure place for the storage of detergents, disinfectants and other similar substances;

(h) facilities for cleaning & disinfecting of tanks used for transporting dairy products and raw milk. Thesecontainers have to be cleaned after every use.

(2) Dairy establishments shall have working areas of sufficient size for work to be carried out under adequatehygienic conditions; their design and layout shall be such as to preclude contamination of the raw materials and the dairyproducts.

(3) In areas where raw materials are handled and dairy products are manufactured, the areas shall have the following:

(a) soild, waterproof flooring which is easy to clean and disinfect and which allows water to drain away, andequipment to remove water;

Page 33: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

442 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(b) walls which have smooth surfaces and are easy to clean, are durable and impermeable and which arecovered with light-coloured coating;

(c) ceilings or roof linings which are easy to clean in those areas where exposed or non-packaged raw materialsor dairy products are handled;

(d) doors made of non-corrodible materials which are easy to clean;

(e) ventilation and, where necessary, good steam and water-vapour extraction facilities in accordance withFactory Act, 1948;

(f) adequate natural or artificial lighting in accordance with Factory Act, 1948;

(g) an adequate number of facilities with hot and cold running water, or water pre-mixed to a suitable temperature,for cleaning and disinfecting hands; taps in work rooms and lavatories for cleaning and disinfecting hands whichshall be non hand-operable (e.g. foot operated, sensor operated etc.), these facilities shall be provided with cleaningand disinfecting materials and a hygienic means of drying hands; and

(h) facilities for cleaning tools, equipment and installations.

(4) The occupier of a dairy establishment shall take appropriate measures to avoid cross-contamination of dairyproducts in accordance with the cleaning program specified earlier.

(5) Where a dairy establishment produces food stuffs containing dairy products together with other ingredients,which have not undergone heat treatment or any other treatment having equivalent effect, such dairy products andingredients shall be stored separately to prevent cross-contamination.

(6) The production of heat-treated milk or the manufacture of milk-based products, which might pose a risk ofcontamination to other dairy products, shall be carried out in a clearly separated working area.

(7) Instruments and equipment used for working on raw materials and dairy products, floors, ceilings or roof linings,walls and partitions shall be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a sourceof contamination to raw materials or dairy products.

(8) Equipment, containers and installations which come into contact with dairy products or perishable raw materialsused during production shall be cleaned and if necessary disinfected according to a verified and documented cleaningprogramme.

(9) Equipment, containers, instruments and installations which come into contact with microbiologically stable dairyproducts and the rooms in which they are stored shall be cleaned and disinfected according to a verified and documentedFood Safety management system programme drawn up by the occupier of the dairy establishment.

(10) The processing establishment shall in principle be cleaned according to a established, verified and documentedFood safety management programme. The manufacturer / shall take appropriate measures to avoid any kind of crosscontamination.

(11) Disinfectants and similar substances used shall be used in such a way that they do not have any adverse effectson the machinery, equipment, raw materials and dairy products kept at the dairy establishment. They shall be in clearlyidentifiable containers bearing labels with instructions for their use and their use shall be followed by thorough rinsing ofsuch instruments and working equipment with potable water, unless supplier’s instructions indicate otherwise.

(12) Any container or tank used for transporting or storage of raw milk shall be cleaned and disinfected before re-use.

II. Personal Hygiene Requirements

(1) The Food Business Operator shall employ those persons only in such an establishment to work directly with andhandle raw materials or dairy products if those persons have proved to the occupier’s satisfaction by means of a medicalcertificate, on recruitment, that there is no medical impediment to their employment in that capacity.

(2) Persons working directly with and handling raw materials or dairy products shall maintain the highest standardsof personal cleanliness at all times. In particular they shall

(a) wear suitable, clean working clothes and headgear which completely encloses their hair;

Page 34: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 443

(b) not smoke, spit, eat or drink in rooms where raw materials and dairy products are handled or stored;

(c) wash their hands at least each time work is resumed and whenever contamination of their hands hasoccurred; e.g. after coughing / sneezing, visiting toilet, using telephone, smoking etc.

(d) cover wounds to the skin with a suitable waterproof dressing. No person with injury on hand, even withdressing, shall be placed in any product making/handling section.

(e) avoid certain hand habits - e.g. scratching nose, running finger through hair, rubbing eyes, ears and mouth,scratching beard, scratching parts of bodies etc. that are potentially hazardous when associated with handling dairyproducts, and might lead to food contamination through the transfer of bacteria from the employee to productduring its preparation. When unavoidable, hands should be effectively washed before resuming work after suchactions

(3) The occupier shall take all necessary measures to prevent persons liable to contaminate raw materials and dairyproducts from handling them until the occupier has evidence that such persons can do so without risk of contamination.

III. Sanitary Requirements for Storage

(1) Immediately after procuring, raw milk shall be placed in a clean place, which is suitably equipped so as to preventany kind of contamination.

(2) Where raw milk is collected daily from a producer, it shall, if not collected and brought to the dairy plant withinfour hours of milking, be cooled as soon as practicable after procuring to a temperature of 4ºC and maintained at thattemperature until processed;

(3) Upon acceptance at a processing establishment milk shall, unless heat-treated immediately, be cooled to atemperature of 4ºC or lower, if not already at such temperature, and maintained at that temperature until heat-treated.

(4) When the pasteurization process is completed, pasteurized milk shall be cooled immediately to a temperature of4ºC or lower.

(5) Subject to Paragraph 7 below, any dairy product not intended to be stored at ambient temperature shall be cooledas quickly as possible to the temperature established by the manufacturer of that product as suitable to ensure itsdurability and thereafter stored at that temperature.

(6) Where dairy products other than raw milk are stored under cooled conditions, their storage temperatures shall beregistered and the cooling rate shall be such that the products reach the required temperature as quickly as possible.

(7) The maximum temperature at which pasteurized milk may be stored until it leaves the treatment establishmentshall not exceed 5ºC.

(8) Dairy products not intended to be stored at ambient temperature shall be cooled as quickly as possible to thetemperature established by the manufacturer of that product as suitable to ensure its durability and shelf life.

(9) Where dairy products other than raw milk are stored under cool conditions, their storage temperatures shall berecorded and the cooling rate shall be adjusted in such a way that the products reach the required temperature at theearliest.

IV. Wrapping and Packaging

(1) The wrapping packaging of dairy products shall take place under satisfactory hygienic conditions and in roomsprovided for that purpose.

(2) The manufacture of dairy products and packaging operations may take place in the same room if the followingconditions are satisfied: —

(a) the room shall be sufficiently large and equipped to ensure the hygiene of the operations;

(b) the wrapping and packaging shall have been brought to the treatment or processing establishment inprotective cover in which they were placed immediately after manufacture and which protects the wrapping orpackaging from any damage during transport to the dairy establishment, and they shall have been stored thereunder hygienic conditions in a room intended for that purpose;

Page 35: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

444 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(c) the rooms for storing the packaging material shall be free from vermin and from dust which could constitutean unacceptable risk of contamination of the product and shall be separated from rooms containing substanceswhich might contaminate the products. Packaging shall not be placed directly on the floor;

(d) packaging shall be assembled under hygienic conditions before being brought into the room, except in thecase of automatic assembly or packaging, provided that there is no risk of contamination of the products;

(e) packaging shall be done without delay. It shall be handled by separate group of staff having experience inhandling and product wrapping and

(f) immediately after packaging, the dairy products shall be placed in the designated rooms provided forstorage under required temperature.

(3) Bottling or filling of containers with heat-treated milk and milk product shall be carried out hygienically.

(4) Wrapping or packaging may not be re-used for dairy products, except where the containers are of a type whichmay be re-used after thorough cleaning and disinfecting.

(5) Sealing shall be carried out in the establishment in which the last heat-treatment of drinking milk or liquid milk-base products has been carried out, immediately after filling, by means of a sealing device which ensures that the milk isprotected from any adverse effects of external origin on its characteristic. The sealing device shall be so designed thatonce the container has been opened, the evidence of opening remains clear and easy to check.

Part-IV

Specific Hygienic and Sanitary Practices to be followed by Food Business Operators engaged in Slaughter of MeatAnimals, Processing, Manufacture, Storage & Sale of Meat and Meat Products

A. Slaughter House

Every person / establishment who slaughters large and small animals including sheep and goat or poultry birdswithin the premises of his factory for production of meat/ meat products for supply / sale/ distribution to the public shallcomply with the following requirements:

(1) General Requirements:

1.1 No Objection Certificate to be obtained from local Authority before grant of licence.

(2) Location of Premises:

Such establishments / Slaughter Houses should preferably be located away from Vegetable, fish or other foodmarkets and shall be free from undesirable odour, smoke, dust or other contaminants. The premises shall be locatedat an elevated level in a sanitary place.

(3) Premises requirements:3.1 The slaughter house shall have a reception area/animal holding yard/resting yard, lairage, slaughter hall,

side halls for hide collection, paunch collection, offals collection, and separation, holding room for suspected/condemned carcass, by-product harvesting, staff welfare inspector’s office, refrigeration room/cold room etc.

3.2 Every such establishment / Slaughter House shall make separate provision in the slaughter hall for theslaughter of different species which are proposed to be slaughtered (like large animal viz; Cattle and Buffalo, Pigsand small animals like Sheep & Goat) and for different methods of slaughter (like Halal, Jewish and Jhatka) After endof the day’s operation the slaughter house shall be cleaned, washed wiped/dried and sanitized thoroughly.

3.3 The slaughter house shall have separation between clean and dirty sections and shall be so organized thatfrom the introduction of a live animal into the slaughter house up to the emergence of meat and offal classed as fitfor human consumption, there shall be a continuous forward movement without any possibility of reversal, intersectionor overlapping between the live animal and meat, and between meat and by-product or waste.

3.4 The reception area/animal holding yard/ resting yard shall have facilities for watering and examininganimals before they are sent to holding pens/lairage. Animals suspected of contagious or infectious diseases shallbe segregated and kept in separate isolation pens which shall also be provided with arrangements for watering andfeeding. After confirmation of any notifiable disease, the designated Veterinary Authority shall notify the disease asper the existing procedures. The resting yard must have overhead protective shelter.

Page 36: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 445

3.5 The lairage shall be adequate in size for the number of animals to be laired.

3.6 Separate space shall be provided for stunning (Wherever applicable), for collection of blood and fordressing of the carcasses. The slaughtering of an animal shall not be done in the sight of other animals. Thedressing of the carcass shall not be done on the floor. Suitable hoists will be provided to hang the carcass before itis eviscerated.

3.7 All the floors in lairage, slaughter halls, work rooms and hanging rooms shall be of impervious and non-slippery material.

3.8 The internal walls will be paved with impervious glazed tiles up to 1 meter height in case of poultry andsmall animal ruminants and 5 meter height in case of large animals/ ruminants. The walls and floors should bepreferably epoxy coated so as to avoid accumulation/absorption of dust, blood/meat particles and microbial/fungalgrowth.

3.9 Ceiling or roofs shall be so constructed and finished and as to minimise condensation, mould development,flaking and accumulation of dirt.

3.10 Suitable and sufficient accommodation shall be provided for segregation, storage and disposal ofcondemned meat.

3.11 The establishments / Slaughter Houses shall be so constructed and maintained as to permit hygienicproduction.

3.12 Windows, doors and other openings which are screened shall be fly proof. All doors shall have strongsprings so that they may close automatically.

3.13 All operations in connection with the preparation or packing of meat / meat food products shall be carriedout under strict hygienic conditions. No portion of the establishments / Slaughter Houses premises shall ever beused for living or sleeping purposes unless it is separated by a wall.

3.14 There shall be efficient drainage and plumbing systems and all drains and gutters shall be properly andpermanently installed. There shall be provision for the disposal of refuse.

3.15 The drainage system for blood shall either be underground with facility for easy cleaning or a portablereceptacle with lid. All drainages will have traps and screens so as to prevent entry of predators like rats, mice,vermin etc.

3.16 The rooms and compartments where edible products are handled shall be separate and distinct from therooms and compartments for inedible products.

3.17 Suitable and separate space shall be provided for the storage of hides and skins. This room shall have aseparate exit.

3.18 A constant and sufficient supply of clean potable cold water with pressure hose pipes and supply of hotwater should be made available in the slaughter hall during working hours.

3.19 Suitable and sufficient facilities shall be provided for persons working in the slaughter house for changingtheir clothes and cleaning their footwear and cleaning their hands before entering rooms used for the preparationand storage of meat.

3.20 Provision for latrines, toilets and change rooms shall be made. Wherever five or more employees of eithersex are employed, a sufficient number of latrines, urinals, washbasins and bathrooms for each sex shall be provided.

3.21 Suitable and sufficient facilities shall be provided in convenient places within the slaughter house for thesterilisation of knives and sharpeners (mushtala) and other equipment used in the slaughter house. The knives andsharpeners (mushtala) shall be of stainless steel only.

3.22 Whenever the dressed meat is not used up for the preparation of meat food products and some portionhas to be stored without further immediate processing, such storage shall be in a room maintained at 0o C to 2o C.

3.23 All slaughter house refuse and waste materials will be suitably processed to prepare animal by-productsor dumped in pits that are suitably covered so as to prevent its access to scavengers. For large slaughter houses, asuitable provision of ETP will be made. Clearance from Environment Control Pollution Board would be mandatoryfor such slaughter houses.

Page 37: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

446 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

3.24 In case of slaughter houses equipped to slaughter equal or less than 50 large animal, 150 small animalsand 1000 poultry birds, waste material should be composted which can be used for manure purpose and in case ofslaughter houses equipped to slaughter more than the above capacity, waste material should be rendered (cooked)in a rendering plant to produce meat and bone meal and inedible fats.

3.25 Suitable and sufficient facilities shall be provided for the isolation of meat requiring further examinationby the authorised veterinary officer in a suitable laboratory within the premises of the slaughter house.

3.26 Consistent with the size of the factory (slaughter house or meat processing unit or an integrated plant)and volume and variety of meat food products manufactured, a laboratory shall be provided, equipped and staffedwith qualified (Chemist/Analyst and Veterinary Microbiologist)* and trained personnel. The Licensing Authorityshall accord approval of the laboratory after inspection.

3.28. Adequate natural or artificial lighting should be provided throughout the abattoir / meat processing unit.The lighting should not alter colors and the intensity should not be less than 540 Lux (50 foot candles) at allinspection points, 220 Lux ( 20 foot candles) in work rooms and 110 Lux (10 foot candles) in other areas. Light bulbsand fixtures suspended over meat in any stage of production should be of safety type and protected to preventcontamination of meat in case of breakage. As far as possible, meat inspection shall be carried out in the day light.Every abattoir shall be provided with well distributed artificial light.

(4) Sanitary Practices:

4.01 Every part of the internal surface above the floor or pavement of such slaughter house shall be washedthoroughly with hot lime wash within the first 10 days of March, June, September and December. Every part of thefloor or pavement of the slaughter house and every part of the internal surface of every wall on which any blood orliquid refuse or filth may have been spilt or splashed or with which any offensive or noxious matter have beenbrought into contact during the process of slaughtering, dressing and cutting, shall be thoroughly cleaned, washedwith water, wiped/dried and disinfected within three hours after the completion of slaughter.

4.02 Rooms and compartments in which animals are slaughtered or any product is processed or prepared shallbe kept sufficiently free from steam, vapours and moisture and obnoxious odours so as to ensure clean and hygienicoperations. This will also apply to overhead structures in those rooms and compartments.

4.03 All parts of the establishments / Slaughter Houses shall always be kept clean, adequately lighted andventilated and shall be regularly cleaned and disinfected. The floorings shall be impervious and washed daily. Limewashing, colour washing or painting as the case may be, shall be done at least once in every twelve months.

4.04 All yards, outhouses, stores and all approaches to the establishments / Slaughter Houses shall always bekept clean and in a sanitary condition.

4.05 Suitable and sufficient receptacles furnished with closely fitted covers shall be provided for collectionand removal of all garbage, filth and refuse from the slaughter house at convenient time to a place away from theslaughter house for disposal.

4.06 All blood , manure, garbage, filth or other refuse from any animal slaughtered and the hide, fat, viscera andoffal there from, shall be removed from the slaughter house within 8 hours after the completion of the slaughteringand in such a manner and by such means as will not cause nuisance at the premises or elsewhere. Every such vesselor receptacle shall be thoroughly cleaned and disinfected immediately after use and shall be kept thoroughly cleanwhen not in actual use.

4.07 The inner side of the skin shall not be rubbed or caused to be rubbed upon the ground within any portionof the slaughter hall. Hides and skins shall not be dragged within the slaughter hall. No gut-scraping, tripe cleaning,manufacture or preparation of meat food products, household washing of clothes or work of any nature other thanis involved in the slaughter and dressing of the carcass shall be permitted in any slaughter hall except in theadjuncts to the slaughter hall intended for these products and purposes.

4.08 The premises shall be cleaned thoroughly with disinfectants, one day in advance of production of meatfood products and the equipments shall be sterilised / sanitised before use. The rooms and compartments in which

* The Chemist/Analyst shall have passed graduation with Chemistry as one of subjects and the Veterinary Microbiologist shall be a QualifiedVeterinarian.

Page 38: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 447

any meat food product is prepared or handled shall be free from dust and from odours emanating from dressingrooms, toilet rooms, catch basins, hide cellars, casing rooms and livestock pens.

4.09 Every practicable precaution shall be taken to exclude flies, rats, mice and vermin from the establishments/ Slaughter Houses. The use of poisons for any purpose in rooms or compartments where any unpacked product isstored or handled is forbidden. The use of approved bait poisons in hide cellars, compartments where inedibleproducts are stored, outhouses or similar buildings containing canned products is, however, not forbidden. However,they should be at designated places and secured.

4.10 It shall be ensured that dogs, cats or birds do not have access to the slaughter hall. Open areas in thefactory shall be covered by wire rope netting to prevent carrion birds from access to the slaughter hall or the factory.

4.11 Water used in the establishments / Slaughter Houses shall be potable and suitable arrangements shall bemade if bore well water is used for production of meat and meat products. If required by the licensing authority, thewater shall be got examined chemically and bacteriologically by a recognised laboratory. The water quality shallcomply with the standards prescribed by the licensing Authority.

4.12 Warm meat’ meant for immediate sale need not be stored in cool conditions. It can be transported insuitable a hygienic and sanitary condition in clean insulated containers with covers (lids) to the meat shops/sellingunits with precautions to ensure that no contamination/cross contamination or deterioration takes place.

(5) Equipment & Machinery:

5.1 The equipment and fittings in slaughter hall except chopping blocks, cutting boards and brooms, shall beof such material and of such construction as to enable them to be kept clean. The implements shall be of metal orother cleansable and durable material resistant to corrosion.

5.2 No vessel, container or other equipment, the use of which is likely to cause metallic contaminationinjurious to health shall be employed in the preparation, packing or storage of meat food products. (Copper or brassvessels shall always be heavily lined. No iron or galvanised iron shall come in contact with meat food products).

(6) Personnel Hygiene:

6.1 No person suffering from infectious or contagious diseases shall be allowed to work in the abattoir.Arrangements shall be made to get the abattoir staff medically examined at such intervals as the licensing authoritydeems fit, to ensure that they are free from infectious, contagious and other diseases. A record of these examinationssigned by a registered medical practitioner shall be maintained for inspection.

6.2 The staff shall be inoculated against the enteric group of diseases once a year and a certificate thereof shallbe kept for inspection.

6.3 In case of an epidemic, all workers should be inoculated or vaccinated.

6.4 The workers working in processing and preparation shall be provided with proper aprons and head wearswhich shall be clean. The management shall ensure that all workers are neat, clean and tidy.

B. Animal Welfare:

Animal welfare is a major concern in meat production. It is essential that animals be reared, handled, transported,and slaughtered using humane practices. A healthy and peaceful animal is an essential requirement for hygienic slaughterand safety of the meat product. Careful handling of animals during loading / unloading, transportation and at slaughteringhelps in improving the quality of meat and reduction in losses in the value of the carcass/meat.

(1) General:

(a) The floor of the lairage and slaughter area should not cause slipping or falling of animals.

(b) Vocalization is an indicator of animal discomfort and need to be watched for.

(c) Use of electric pods for moving animal should be discouraged. Movement of animals can be managed bygrouping, use of plastic wrapped sticks etc.

(d) Pen stocking density should be monitored. All animals should have room to lie down simultaneously. Thecondition of animals arriving for slaughter should be closely monitored so that injured, diseased animals are notslaughtered.

Page 39: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

448 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(e) High pitch sounds such as whistling and yelling should be avoided to spare distress to animals.

(f) The following factors have been identified as critical to animal welfare:

(1) Supervision and training of employees.

(2) Proper designing of animal transport cart and unloading bay.

(3) Proper construction of holding/resting pen, stunning box, maintenance of stunning equipment,restraining systems, gates and other animal handling equipment.

(4) Avoiding distractions that make animals refuse to move.

(5) Monitoring the condition of animals arriving at the plant.

(6) Proper design of equipment in the slaughter house.

(2) Humane treatment of animals brought for slaughter:

(a) Pre-slaughter handling of animals should be carefully done to reduce stress. Resting of the animals isessential. Only animals which are disease free and in a condition to walk should be brought for slaughter.

(b) Distractions that impede animal movements such as, reflections, air blowing towards animals and movementor high pitch noise, need to be avoided. Herding of animals should not be done through electric prods but with thehelp of plastic bags or sticks.

(c) A high standard of training is required for employees to ensure that the basic hygiene and safety practicesare followed while handling animals.

(d) Equipment which is used for slaughter such as captive bolt stunner, gates, hooks etc should be kept ingood working condition and cleanliness of floors etc. needs to be ensured. There should be daily check to ensurethe smooth working of equipment and cleanliness of floors.

(e) No animal shall be administered any chemical, drug or hormone before slaughter except for its treatment asprescribed by the Qualified Veterinarian and the withdrawal period for the particular drug has been observed.

(f) Inspecting personnel should pay particular attention to these points to ensure reasonable standards ofanimal welfare.

(3) Poultry welfare:

The conditions under which broilers are housed and the way that they are managed during their growingphase, transportation and slaughter are set down in several government/industry endorsed Model Codes of Practicedesigned to safeguard their welfare.

A model welfare program needs to be developed for pick-up, transport and broiler/chicken processing sectors.Processing unit shall incorporate elements of this welfare audit in their own quality plans & manuals.

I. Poultry Welfare programme shall include following:

Poultry Suppliers and processors must have a documented program for poultry welfare envisaging following;

(1) Catching: Poultry intended for slaughter plant should be clean and in good health. Every reasonableprecaution should be taken to minimize injury to poultry. The catcher needs to be trained to this effect.

(2) Transport: For transport of poultry, crates shall be in good condition. There shall be no crate/cagedamage that would allow injury to poultry or allow crates to accidentally open. Transport crates should not beover-filled and enough space should be provided to allow all poultry to lie down.

(3) Holding: Poultry held in sheds should be provided adequate ventilation and climate control such asfans or curtains.

(4) Stunning: Stunning equipment should be maintained to confirm that poultry are insensible prior toslaughter, and the time between stunning and slaughter should be limited to minimize any likelihood thatpoultry may regain consciousness prior to slaughter.

Page 40: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 449

II. Humane slaughter (poultry):

While the chickens are reared specifically for human consumption and they therefore at some stagehave to be slaughtered, they should be slaughtered in a humane manner, and all poultry are stunned (renderedinsensible to pain) prior to slaughter.

Slaughter equipment at all supply facilities should be properly maintained to confirm that the poultry areslaughtered quickly.

(4) Pre Slaughter Handling of Animal:

Livestock are transported en masse from the farm to the slaughterhouse, a process called “live export”.Depending on its length and circumstances, this exerts stress and injuries on the animals and some may die enroute. Apart from being arguably inhumane, unnecessary stress in transport may adversely affect the quality of themeat. In particular, the muscles of stressed animals are low in water and glycogen, and their pH fails to attain acidicvalues.

(5) Transportation of Animals

Following requirements shall be satisfied for Transportation of Animals from a farm to the slaughter house.

I. General Conditions during animal transport:

(a) Only healthy animals in good condition shall be transported unless they are meant for emergencyslaughter. These animals should be certified by a qualified veterinary inspector for freedom from infectiousdiseases and ecto-parasitic diseases and their fitness to undertake the journey.

(b) When animals are to be transported from endemic areas of a disease to non-endemic areas, appropriatesteps shall be taken to ensure that animals are free from notifiable disease and also prescribed protective stepsincluding vaccination are taken in this regard.

(c) Female animals in advanced stages of pregnancy shall not be transported.

(d) When transporting large animals particularly boar/bull, special arrangements by providing suitablepartitions should be made to protect the animals from infighting. Similar arrangements should also be made toprotect the young ones from being crushed when they are transported.

(e) To avoid exhaustion, the animals shall be given humane treatment and care during transportation.The animals shall not be bound or chained during transit and space provided for them shall be large enoughto stand or lie without difficulty.

(f) An attendant along with first aid equipment shall accompany the animals in transit.

(g) Before loading, the animals should not be fed heavily. Only light feed may be allowed. For journeysless than 12 hours no feed may be carried but for longer journeys sufficient feed shall be carried to last duringthe journey. Watering facilities shall be provided at regular intervals.

(h) Light and heavy animals shall be separated by providing partitions; animals from different pens/sheds preferably shall not be mixed during transportation. Male stock shall not be transported with femalestock (adults).

(i) All vehicles should be inspected for safety, suitability and cleanliness before loading the animals.The floor and walls should be undamaged and there should be no nails or sharp projections which may injurethe animals.

(j) The Vehicles should be thoroughly sprayed with suitable disinfectant before loading the animals.

(k) A layer of clean sand to cover the floor to a thickness of not less than 6 cm shall be provided. Thislayer of sand shall be moistened with water during the summer months. During hot months arrangements shallbe made to sprinkle water on the animals at frequent intervals. In winter, a 2-cm layer of clean sand withanother 6-cm layer of whole-straw shall be provided.

(l) Animals when driven for loading or unloading shall never be struck with stick or other prod. Drivingcould best be done by soft-rubber pipe.

Page 41: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

450 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(m) If animals are to be transported in extreme cold or hot climate, it is preferable to transport them incovered lorries so that they may not die or get exhausted or suffer from acute respiratory disease. Journeysunder such adverse climate shall be minimised.

(n) Each consignment should bear a label showing the following particulars:

(i) Number and kind of the animals loaded;

(ii) Name, address and telephone number, if any, of the consignor;

(iii) Name address and telephone number, if any, of the consignee;

(iv) Instructions regarding feeding and watering.

II. Loading

(a) Loading, during extremes of temperatures shall be avoided.

(b) Suitable ramp shall be provided for loading and unloading the animals. The floor of the ramp shallhave cleats at intervals, so that animals do not slip as they climb or descend. The ramp shall be covered withstraw to avoid slipping. Van at any time of loading and unloading shall be kept clean to avoid slipping ofanimals.

(c) In case of railway wagons, when loading is done on the platform, the door of the wagon may be usedas ramp. In such cases, bails or bags of hay, agricultural wastes etc. may be placed on either side of thedropped door to prevent the animals from getting their legs stuck between the sides of the wagons andplatform.

III. Space Requirements:

(a) Overcrowding shall be avoided. Each animal shall have enough space to lie down.

(b) Railway wagons shall not accommodate more animals than those specified in IS specifications.

(c) The speed of truck transporting animals shall not exceed 40 kilometres per hour, avoiding jerks andjolts. The truck shall not load any other merchandise and shall avoid unnecessary stops on the road.

(d) For journeys, exceeding 12 hours, the animals shall be transported by railway. Loading and shall bedone by evening.

(6) Humane Slaughter:

Animals are slaughtered by being first stunned and then exsanguinated (bled out)

(a) Stunning:

Stunning before slaughter is mandatory. Standard Stunning methods induce temporary loss ofconsciousness and rely on prompt and accurate sticking procedures to cause death. By inducing temporaryunconsciousness and insensibility, stunning avoids and minimizes reactions of fear and anxiety as well aspain, suffering and distress among the animals concerned.

It is important that the equipment utilized for stunning and slaughter is maintained in good workingcondition and that all operators involved are well trained and have a positive attitude towards the welfare ofanimals.

The following methods of stunning can be followed:(i) Mechanical stunning: Mechanical stunning of cattle may be carried out by one of three methods;

captive bolt stunning, mushroom head percussive stunning and pneumatic percussive stunning. For cattle,pneumatic stunning should be preferred and the optimum position is that, the centre of the stunner shouldcontact the animal at a point of intersection of lines drawn from the medial corners of the eyes and the base ofthe ears. The best position for pigs is on the midline just above eye level, with the head directed down the lineof the spinal cord and the optimum position for sheep and goat is behind the poll, aiming towards the angle ofthe jaw. If an animal shows signs of regaining consciousness after the initial stun, the animal must beimmediately killed by the use of a captive bolt gun.

Page 42: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 451

(ii) Electrical stunning: Electrical stunning consists of passing electricity through the brain toproduce instantaneous insensibility. Electrical Head Stunners may be preferred for sheep and goatwhere both electrodes are placed on the head region. Water bath electrical stunning may be used forpoultry birds. A low and controlled voltage must be maintained so that the stunning will not damage theheart and brain or cause physical disability and death to the animals. The minimum current levelrecommended for stunning are indicated in the table below.

Species Minimum current levels for head-only stunning

Cattle 1.5 AmpsCalves (bovines of less than 6 month of age) 1.0 AmpsPigs 1.25 AmpsSheep and goats 1.0 AmpsLambs 0.7 AmpsBroilers 100 milli AmpsTurkeys 150 milli Amps

(iii) Gas stunning: Stunning by exposure to carbon dioxide (CO2) may be preferred for pigs. Theconcentration of CO2 should be 90% by volume but shall not be less than 80% by volume. Ideally, pigs shouldbe exposed for three minutes. Sticking should be done immediately after exit from the gas chamber. Over-crowding of animals should be avoided in the gas chamber.

C. Veterinary Inspection:

Veterinary Inspection which envisages Ante-mortem Inspection of live animals/birds for suitability toslaughter for food/meat purpose, Post mortem inspection after slaughter of animal/bird supported withsubsequent laboratory investigation and testing for necessary confirmation as required, shall be carried outas per the Manual for Veterinary Inspection and Testing and necessary instructions/guidelines/proceduresissued by the Authority.

I. Ante-mortem inspection:

(a) All animals shall be rested before slaughter and shall be subjected to ante-mortem examination andinspection well in advance of the time of slaughter.

(b) No animal which has been received into a slaughter hall for the purpose of being slaughtered shallbe removed from the slaughter hall before being slaughtered except with the written consent of the QualifiedVeterinary Doctor. An animal which, on inspection is found to be not fit for slaughter shall be marked as“suspect” and kept separately. Each such animal shall be marked as “suspect” only by or under the personalsupervision of the Qualified Veterinary Doctor and the marking shall not be removed or obliterated except bythe Qualified Veterinary Doctor himself.

(c) An animal showing signs of any disease at the time of ante-mortem inspection that would cause itscarcass being ultimately condemned on post-mortem shall be marked as “condemned” and rejected.

(d) An animal declared as “suspect” on ante-mortem inspection but which does not plainly show anydisease or condition that would cause its entire carcass to be condemned shall maintain its identity as“suspect” until its carcass and all organs are finally inspected by the Qualified Veterinary Doctor.

(e) No animal in a febrile condition shall be permitted for slaughter. No suspect animal shall be slaughtereduntil all other animals intended for slaughter on the same day have been slaughtered. All animals which, onante-mortem inspection, show symptoms of railroad sickness, parturient paresis, rabies, tetanus or any othercommunicable diseases shall be marked as “condemned” and disposed of in accordance with the provisionscontained in sub paragraph (8) below.

(f) Animals presented for slaughter and found in a dying condition on the premises of a factory due torecent disease shall be marked as “condemned” and disposed of as provided for “condemned” animals.

(g) Every animal which, upon examination, is found to show symptoms of or is suspected of beingdiseased or animals declared as “suspect” shall at once be removed for treatment to such special pen and keptthere for observation for such period as may be considered necessary to ascertain whether the animal isdiseased or not.

Page 43: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

452 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(h) All animals declared as “condemned” on ante-mortem inspection shall be marked as “condemned”and killed if not already dead. Such carcasses shall not be taken into the factory to be slaughtered or dressed,nor shall they be conveyed into any department of the factory used for edible products, but shall be disposedof in the manner as indicated in sub-paragraphs 12 to 15 of paragraph 24 for condemned carcasses.

II. Post-mortem inspection:

(a) A careful and detailed post-mortem examination and inspection of the carcasses and parts thereof ofall animals slaughtered shall be made soon after slaughter. All organs and parts of the carcasses and blood tobe used in the preparation of meat food products shall be held in such a manner as to preserve their identitytill the completion of the post-mortem inspection so that they can be identified in the event of the carcassesbeing condemned.

(b) Every carcass including all detached parts and organs thereof which show evidence of any conditionwhich will render the meat or any part or organ unfit for human consumption and which for that reason mayrequire subsequent inspection, shall be retained by the Qualified Veterinary Doctor. The identity of suchcarcass including the detached parts and organs thereof shall be maintained until the final inspection iscompleted. Retained carcasses, detached parts and organs thereof shall in no case be washed, trimmed ormutilated in any manner unless otherwise authorized by the Qualified Veterinary Doctor.

(c) No air shall be blown by mouth into the tissues of any carcass or part of a carcass.(d) Every carcass or part thereof which has been found to be unfit for human consumption shall be

marked by the Qualified Veterinary Doctor as “Inspected and condemned”.(e) All such condemned carcasses, parts and organs thereof shall remain in the custody of the Qualified

Veterinary Doctor pending disposal at or before the close of the day on which they are marked “Inspected andcondemned” in accordance with sub-paragraphs (11),(12) and (13) below.

(f) Carcasses, parts and the organs thereof found to be sound, wholesome, healthful and fit for humanconsumption shall be marked as “Inspected and passed”.

(g) Carcasses found affected with anthrax before evisceration shall not be eviscerated but condemnedand disposed of immediately in accordance with sub-paragraph (12) below. Any part of a carcass contaminatedwith anthrax infected material through contact with soiled instruments or otherwise shall be immediatelycondemned and disposed of as provided in sub-paragraph (12) below.

(h) The portion of the slaughtering department including equipment, employees’ boots and aprons,etc., contaminated by contact with anthrax material shall be cleaned and thoroughly disinfected immediately.

(i) When on inspection only a portion of a carcass on account of slight bruises is decided to becondemned, either the bruised portion shall be removed immediately and disposed of in accordance with sub-paragraph (13) below or the carcass shall be retained and kept till such time it is chilled and the bruised portionremoved and disposed of as provided above.

(j) Post-mortem inspection shall be a detailed one and shall cover all parts of the carcass, the viscera,lymph glands and all organs and glands.

(k) The post-mortem inspection shall be in accordance with the general rules laid down for such inspectionin public slaughter houses under the control of local bodies besides special instructions that may be issuedfrom time to time by the licensing authority.

(l) All condemned carcasses, organs or parts thereof shall be completely destroyed in the presence ofthe Qualified Veterinary Doctor by incineration or denatured, after being slashed freely with a knife, with crudecarbolic acid, cresylic- disinfectant or any other prescribed agent unless such carcasses, organs or partsthereof are sterilized for the preparation of bone-cum-meat meal before leaving the slaughter house premises,subject to sub-paragraph (13) below.

(m) Carcasses, organs or parts thereof condemned on account of anthrax shall be disposed of either by(i) complete incineration or (ii) thorough denaturing with prescribed denaturant in the manner prescribed inthe foregoing paragraphs and also in accordance with the rules and regulations prescribed by the localauthority.

(n) Destruction of condemned carcasses, organs or parts thereof shall be carried out under the directsupervision of the Qualified Veterinary Doctor.

Page 44: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 453

(o) If in the opinion of the Qualified Veterinary Doctor a carcass, organ or part thereof is to be held backfor further detailed examination the carcass, organ or part concerned shall not be released till the examinationin detail is completed by the Qualified Veterinary Doctor and it is declared thereafter by him as fit. When it isto be detained for detailed examination, the carcass, organ or part thereof shall be marked as “Held”. If onsubsequent inspection, the carcass, organ or part thereof is found to be unwholesome and unfit for humanfood, the Qualified Veterinary Doctor shall mark such a carcass, organ or part thereof as “condemned” andshall dispose it as described in the foregoing paragraphs.

D. Sanitary and Hygienic Requirements for Meat processing units:

Following Sanitary and Hygienic requirements shall be satisfied in the meat processing unit.

(1) Location:

1.1 Meat processing unit should be located in areas not subjected to regular and frequent flooding and freefrom objectionable odours, smoke dust and other contaminants;

1.2 Roadways and areas serving the meat processing unit which are within its boundaries or in its immediatevicinity should have a hard paved surface suitable for wheeled traffic. There should be adequate drainage andprovision for cleaning;

1.3 Where appropriate meat processing unit should be so designed that access can be controlled.

(2) Building and Facilities:

2.1 The meat processing unit should provide working space for the satisfactory performance of all operations.

2.2 The construction should be sound and ensure ventilation, good natural or artificial lighting and easycleaning.

2.3 The meat processing unit should be laid out and equipped so as to facilitate proper supervision of meathygiene including performance of inspection and control;

2.4 The meat processing unit should be of such construction as to protect against the entrance and harbouringof insects, birds, rodents or other vermin as well as the entry of environmental contaminants such as smoke, dustetc.

2.5 Buildings and facilities should be designed to provide separation by partition, location or other effectivemeans, between those operations which may cause cross- contamination;

2.6 Meat processing unit should be laid out and equipped so as to ensure, that edible meat does not come intocontact with floors, walls or other fixed structures, except those which are specifically designed for contact withmeat;

2.7 The construction and lay out of any chilling room, freezing room, freezer store or freezer should satisfy therequirements of these rules;

2.8 In meat handling areas :

(a) Floors should be of waterproof, non-absorbent, washable non-slippery and nontoxic materials,without crevices and should be easy to clean and slope sufficiently for liquids to drain to trapped outlets;

(b) Walls should be of waterproof, non-absorbent, washable and nontoxic materials and should be lightcoloured. Up to a height of at least 1.5 metres,

(c) they should be smooth and without crevices, and should be easy to clean and walls and floors andbetween walls and ceilings should be sealed and covered to facilitate cleaning;

(d) Ceilings should be so designed, constructed and finished as to prevent any accumulation of dirt andminimize condensation, mould development and flaking and should be easy to clean;

(e) Windows and other openings should be so constructed as to avoid accumulation of dirt and thosewhich open should be fitted with insect screen. Screens should be easily movable for cleaning and kept ingood repair. Internal window sills, if present, should be sloped to prevent use as shelves;

(f) Doors should have smooth, non-absorbent surfaces and where appropriate, be self-closing andclose fitting; and

Page 45: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

454 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(g) Stairs lift cages and auxiliary structures such as platforms, ladders, chutes, should be so situatedand constructed as not to cause contamination of meat. They should be capable of being effectively cleaned.Chutes should be constructed with inspection and cleaning hatches;

2.9 The use of construction materials which cannot be cleaned and disinfected such as wood, should beavoided unless its use would clearly not be a source of contamination, and

2.10 Office accommodation should be provided for the use of the meat inspection agency.

(3) Sanitary Facilities:

3.1 Water Supply:

3.1.1. An ample supply of potable water under pressure should be available with facilities for its storage,where necessary for distribution, and with protection against contamination;

3.1.2. Supply of hot potable water should be available at all times during working hours;

Note – This provision is intended to cover water for both cleaning purposes and the destruction of microorganisms(especially those pathogenic to man) on knives, utensils etc., and coming into direct contact with meat. Forcleaning purposes the temperature of the water should be 65 degree Celsius. The hot water for disinfectionpurposes should be at 82 degree Celsius and dispensed in such a way (e.g. in specially designed boxes near theworking area) that blades of knives etc., can be submerged in the water for contact time not less than two minutes.Often this water supply is separate from other hot water supplies used for cleaning, hand washing etc. But ifthere is only one hot water supply the term “ample” should mean that even at times where large amounts of hotwater is used (e.g. during cleaning operations) the water supply from any tap in the establishment should not bedecreased.

3.1.3 Ice should be made from potable water and should be manufactured, handled and stored so as toprotect it from contamination; and

3.1.4 Steam used in contact directly with meat should be produced from potable water and contain nosubstances which may be hazardous to health or may contaminate the food.

3.2 Effluent and Waste Disposal: Meat processing unit should have an efficient effluent and wastedisposal system. All effluent lines (including sewer systems) should be large enough to carry peak loads andshould be constructed in such a manner as to avoid contamination of potable water supplies. Biologicaloxygen demand level shall be less than 1500, and for that an effluent treatment plant, if necessary may beinstalled.

3.3 Facilities for Storage of Waste and Inedible Material: Facilities should be provided for the storage ofwaste and inedible material prior to removal from the establishment. These facilities should be designed toprevent access to waste or inedible material by pests and to avoid contamination of food, potable water andequipment or building.

3.4 Changing Facilities and Toilets: Suitable and conveniently located changing facilities and toiletsshould be provided in all establishments. Toilets should be so designed as to ensure hygienic removal ofwaste matter. These areas should be well lit and ventilated and should not open directly on to food handlingareas. Hand washing facilities with warm or hot and cold water with suitable hygienic means of drying handsshould be provided adjacent to toilets and in such a position that the employee must pass them whenreturning to the processing area. Where hot and cold water are available mixing, taps should be provided.Where paper towels are used, a sufficient number of dispensers and receptacles should be provided near toeach washing facility. Taps of non-hand operable type are preferable. Notices should be posted directingpersonnel to wash their hands after using the toilets.

3.5. Hand Washing Facilities in Processing Areas:

3.5.1 Adequate and conveniently located facilities for hand washing and drying should be providedwherever the process demands. Where appropriate, facilities for hand disinfection should be provided. Thefacilities should be furnished with properly trapped waste pipes leading to drains.

3.5.2 All rooms used for deboning, preparing, packing or other handling of meat should be equippedwith adequate facilities for cleaning and disinfecting implements, conveniently located for the use of personnel

Page 46: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 455

during operations. These facilities are for use exclusively in the cleaning and disinfection of knives, steels,cleavers, saws and other implements.

3.5.3 All facilities for cleaning and disinfecting implements should be of such nature and sizes as topermit proper cleaning and disinfection of implements . These facilities should be constructed of corrosion –resistant materials and should be capable of being easily cleaned.

3.5.4 All facilities for cleaning and disinfecting of implements should be fitted with suitable means ofsupplying hot water in sufficient quantity at all times while meat is being handled in that part of the MeatProcessing Unit.

3.5.5 Lighting: Adequate natural or artificial lighting should be provided throughout the meat processingunit. Where appropriate, the lighting should not alter colours and the intensity should not be less than

540 Lux (50 foot candles) at all inspection points.

220 Lux (20 foot candles) in work rooms.

110 Lux (10 foot candles) in other areas.

Light bulbs and fixtures suspended over meat in any stage of production should be of a safety typeand protected to prevent contamination of meat in case of breakage.

3.6 Ventilation: Ventilation should be provided to prevent excessive heat, steam condensation, dust andto remove contaminated air. The direction of the air flow should never be from a dirty area to clean area.Ventilation openings should be provided with an insect screen or other protective enclosure of non-corrodiblematerial. Screens should be easily removable for cleaning.

(4) Equipment and Utensils :

4.1 Materials – All equipments, implements and utensils used in establishments which come into contact withexposed meat and meat products should present a smooth impervious surface and be resistant to corrosion andshould be made of material which is non-toxic, does not transmit odour or taste, is free from pits and crevices, is non-absorbent and capable of withstanding repeated exposure to normal cleaning and disinfection. Such equipmentshould be so constructed that they may be easily cleaned.

4.2 Sanitary Design, Construction and Installation:4.2.1 All equipments and utensils should be so designed and constructed as to prevent hygienic

hazards and permits easy and thorough cleaning and disinfection and where practicable be visible for inspection.Stationary equipment should be installed in such a manner as to permit easy access and thorough cleaning.

4.2.2 Containers for inedible material and waste should be leak proof, constructed of non- corrosivemetal or other suitable impervious materials which should be easy to clean or disposable and where appropriate,able to be closed securely; and

4.2.3 All refrigerated spaces should be equipped with temperature measurement or recording devices.4.3 Equipment Identification: Equipment and utensils used for inedible material or waste should be so identified

and should not be used for edible products.

(5) Hygiene Requirements :

5.1 Maintenance. The buildings, rooms, equipment and all other physical facilities of the meat processing unit,including drains, should be maintained in good repair and in orderly condition. Except for rooms where meatprocessing or cleaning operations are performed, they should be free from steam, vapour and surplus water.

5.2 Cleaning and Disinfection – Cleaning and disinfection should meet the following requirements:(a) Amenities provided for the use of employee and the inspection service including changing facilities,

toilets and the inspection office space should be kept clean at all times.(b) If rooms, intended and most of the time used for the handling, preparation, processing, packaging on

storage of meat, are used for any other food preparation purposes, then cleaning and disinfection are necessaryimmediately before and after such use.

(c) The temperature in rooms for boning out and trimming should be controlled and held suitably low,unless cleaning of equipment and utensils are carried out at least every four hours;

Page 47: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

456 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(d) To prevent contamination of meat, all equipments, implements, tables, utensils including knives,cleaves, knife pouches, saws, mechanical instruments and containers should be cleaned at frequent intervalsduring the day and immediately cleaned and disinfected whenever they come into contact with diseasedmaterial, infective material or otherwise become contaminated. They shall also be cleaned and disinfected atthe conclusion of each working day.

(e) If any skip or trolley or any container used in a department where edible material is handled, entersan area where inedible material is handled it should be cleaned and disinfected immediately before re-enteringthe edible department.

(f) Immediately after the cessation of work for the day or at such other times as may be required, thefloors and wails should be cleaned to remove contamination. Floor drains should be kept in good conditionand repair with strainers in place; and

(g) Roadways and yards in the immediate vicinity of and serving the meat processing unit should bekept clean.

5.3 Hygiene Control Programme.-It is desirable that each meat processing unit in its own interest designatesa single individual whose duties are diverted from production, to be held responsible for the cleanliness of the meatprocessing unit. His staff should be a permanent part of the organisation or employed by the organisation andshould be well trained in the use of special cleaning tools, methods of dismantling the equipment for cleaning andin the significance of contamination and the hazards involved. A permanent cleaning and disinfection scheduleshould be drawn up to ensure that all parts of the meat processing unit are cleaned appropriately and that criticalareas, equipment and material and designed for cleaning and/or disinfection daily or more frequently if required.

5.4 Storage and Disposal of Waste – Waste material should be handled in such a manner so as to excludecontamination of food or potable water. Precautions should be taken to prevent access to waste by pest. Wasteshould be removed from the meat handling and other working areas at intervals and at least daily. Immediately afterdisposal of the waste, receptacles used for storage and any equipment which has come into contact with the tasteshould be cleaned and disinfected. At least daily the waste storage area should also be cleaned and disinfected.

5.5 Entry of dogs, cats or other pet animals is not allowed to enter meat processing unit.

(6) Pest Control

6.1 There should be an effective and continuous programme for the control of insects, birds, rodents or othervermin. Meat processing unit and surrounding areas should be regularly examined for evidence of infestation.

6.2 Should pests gain entrance to the meat processing unit or surrounding areas, eradication measures shouldbe instituted. Control measures involving treatment with physical or chemical or biological agents should only beundertaken by or under direct supervision of personnel who have a thorough understanding of the potentialhazards to health resulting from the use of these agents, including those which may arise from residues retained inthe product. Such measures should be carried out in accordance with the recommendation of the official agencyhaving jurisdiction and with the full knowledge of its inspector, and

6.3 Pesticides should only be employed if other precautionary methods cannot be used effectively. Onlypesticides approved for use in the meat processing unit by competent authority should be used and the greatestcare should be exercised to prevent any contamination of the meat equipment or utensils. Before pesticides areapplied all meat should be removed from the room and all equipment and utensils should be thoroughly washedprior to being used again.

6.4 Handling and Storage of Hazardous substances – Pesticides or other substance which may represent ahazard should be labelled with a warning about their toxicity and use. Except as required for purpose of hygienesuch substance which may contaminate meat packing material and ingredients should be handled and stored in apart of the meat processing unit which is not used for preparation, processing, handling, packing or storage of meat.They should be handled and dispensed only by authorised and properly trained personnel. Extreme care should betaken to avoid contamination of meat. However, materials employed in the construction and maintenance of anestablishment may be used at any time with the approval of an inspector.

6.5 Personal Effects and Clothing: - Personal effects and clothing should not be deposited in meat handlingareas.

Page 48: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 457

6.6 Maintenance Tools – Cleaning and maintenance tools and products should not be stored in meat handlingarea.

(7) Personnel Hygiene and Health Requirements :

7.1 Medical examination: Persons who come into contract with meat in the course of their work should have amedical examination prior to their employment. Medical examination of a meat handler shall be carried out routinelyand when clinically or epidemiologically indicated, at least once in 12 months.

7.2 Communicable Diseases: The management should take care to ensure that no person, while known orsuspected to be suffering form, or to be a carrier of a disease likely to be transmitted through meat or while afflictedwith infected wounds, skin infections, sores or with diarrhoea, is permitted to work in any area in any capacity inwhich there is any likelihood of such a person directly or indirectly contaminating meat with pathogenicmicroorganisms. Any person so affected should immediately report to the management that he is ill.

7.3 Injuries: Any person who is cut or injured should discontinue working with meat and until he is suitablybandaged should not be engaged in any meat processing unit in the preparation, handling, packing or transportationof meat. No person working in any meat processing unit should wear exposed bandage unless the bandage iscompletely protected by a water proof covering which is conspicuous in colour and is of such a nature that it cannotbecome accidentally detached. First aid facilities should be provided for this purpose.

7.4 Washing of Hands: Every person engaged in a meat handling area should wash his hands frequently andthoroughly with a suitable hand cleaning preparation under running potable water while on duty. Hands shouldalways be washed before commencing work, immediately after using the toilets, after handling contaminated materialand whenever else necessary. After handling diseased or suspect materials hands should be washed and disinfectedimmediately. Notices requiring hand-washing should be displayed.

(8) Personnel Cleanliness:

8.1 Every person engaged in an area in meat processing unit where meat is handled should maintain a highdegree of personnel cleanliness while on duty, and should at all times while so engaged wear suitable protectiveclothing including head covering and foot wear, all of which should be washed unless designed to be disposed andwhich should be maintained in a clean condition consistent with the nature of the work in which the person isengaged.

8.2 Aprons and similar items should not be washed on the floor; and

8.3 Such items should not be left on equipment in the working area.

8.4 Personal Behavior : Any behavior which can potentially contaminate the meat such as eating, use oftobacco, chewing, spitting, should be prohibited in any part of meat processing unit used for the preparation,handling, packaging or transportation of meat.

8.5 Visitors: Every person who visits an area in any meat processing unit where meat is handled should wearclean protective clothing and head cover.

E. Sanitary &Hygienic Requirements for the Retail Meat Shops

For ensuring the hygiene and safety of meat being sold at retail meat shops, the following requirementsshould be followed under the supervision of the qualified Veterinary staff.

(1) Location of Meat Shop

(1) The meat shop / sale outlet should be preferably a unit of meat market located away from Vegetable, fish orother food markets and shall be free from undesirable odour, smoke, dust or other contaminants. Wherever a meatmarkets is not available, individual meat shop can be set up considering the above factors, which have a directbearing on the hygiene conditions of the premises and health of consumers.

(a) The minimum distance between the licensed meat shop and any place of worship should not be lessthan 50 meters;

(b) The condition of 100 meters distance will apply in case the premises situated directly opposite to theentry gate of religious place of any community.

Page 49: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

458 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(c) All the meat shops located in the vicinity of religious places shall be fitted with black glass doors,which must be kept, closed all times except in case of entry or exit. It must be the responsibility of the meatshop owners to maintain a high standard of hygiene not only inside the shops, but also in the way leading tothe shops road pavements or other adjoining place, particularly for insanitary materials originating from themeat business for example, blood, part of offal, meat scraps

(2) Size of Meat Shops

(a) Considering the constraints of commercial space in residential areas in concerned Panchayats /Municipalities the size of meat shops may vary according to the size of business and activities being carried outthere in the meat shops. However it will be desirable that shops are less than 4 sq m of floor area

(b) The height of shop in all above categories of meat shops should be not less than 3 meters, while in case ofair-conditioned meat shops, it should not be less than 2.5 meters.

(3) Premises

(a) The premises shall be structurally sound. The walls up to the height of minimum 5 feet from the floor levelshall be made of impervious concrete material (e.g. glazed tiles or hygienic panels, etc.) for easy washing andcleaning purposes.

(b) The floor should be made of impervious and non-slippery materials with a slope for easy cleaning andremoval of filth, waste and dirty water. The slope of the floor shall not be less than 5 cm. for a floor of 3 meters.

(c) All the fittings in the stall should be of non-corroding and non-rusting type.

(d) All processing tables, racks, shelves, boards, etc. shall have zinc/aluminium/stainless steel/marble-graniteto of facilitate proper cleaning.

(e) A sign board indicating the type of meat sold shall be displayed prominently. Nothing else but meat shouldbe sold at the premises.

(f) The premises should have provision of sewer connection for drainage of wastewater.

(g) There should be provision of continuous supply of potable water inside the premises. In case the watersupply is from bore well the arrangement for softening of water for making the same potable shall be made in thepremises and intermittent store arrangement should be made.

(h) The door of the shop should be of self-closing type, and the sale counter should have a provision for smallwindow with wire glass sliding. The door of the shop should be of dark glass top and be kept closed. No carcassesshould be kept in a manner so as to be seen by the public view from outside.

(4) Ventilation

(a) The meat shop should be ventilated with facility of cross ventilation and may be provided with at-least oneelectric fan and one exhaust fan.

(b) The rails and hanging hooks, if provided for hanging carcasses, should be of non-corrosive metal. Thenon-corrosive hanging hooks for carcasses shall be 30 cm. apart and the distance between rails shall be 60 to 70 cm.depending upon the size of animals slaughtered and carcasses hanged.

(5) Equipment and Accessories

(a) The meat shop should have suitable arrangement for fly proofing in the form of air-curtains, flytraps, etc.

(b) It should have display cabinet type refrigerator of size for maintaining a temperature of 4 to 8 degrees C.or freezing cabinet if the meat is to be stored for more than 48 hours.

(c) The weighing scales used shall be of a type which obviates unnecessary handling and contamination andthe sketch of the scale shall be made of stainless steel or nickel coated.

(d) The knives, tools and hooks used shall be made of stainless steel. Sufficient cupboards or racks should befor storing knives, hooks, clothes and other equipments.

(e) There should be a provision of geysers in all the meat shops to have hot water at a temperature not lessthan 82 degree C to clean the premises and equipment used in meat shop.

Page 50: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 459

(f) Washbasin made of stainless steel / porcelain shall be provided with liquid soap dispenser or other soapand nail brush for thorough cleaning of hands.

(g) The chopping block should be of food-grade synthetic material, which does not contaminate the meat. Ifthe block is of wooden it should be of hardwood trunk, which is solid enough and should not contaminate the meat.

(h) A waste bin with a pedal operated cover shall be provided in the premises for collection of waste material.

(6) Transportation

(a) The transportation of carcasses from the slaughter house to the premises shall be done under hygienicconditions in boxes of adequate size linked with zinc/aluminium/stainless steel or ‘wire gauze meat safes, whichmust be washed daily.

(b) The transportation of carcasses from the slaughter house to the meat shops should be done in insulatedvans refrigerated. Under no circumstances, carcasses will be transported in vehicles used for commuting of humanbeings, or in an exposed condition.

(7) Pest Control

(a) The meat shop should have an effective and continuous programme for control of insects, rodents or othervermin within the premises. The surrounding area of the shop should also be free from insects, birds, rodents andother vermin.

(b) The pest control measures adopted by the owner of shop should be kept as a record in the premises to beshown to any officer of the concerned Panchayats / Municipalities responsible for local administration/Corporationat the time of inspection.

(c) Chlorinated hydrocarbons, organo-phosphorus compounds and synthetic pyrithroids, rodenticides etcshould neither be used as pesticide nor shall be stored at the meat shop.

(d) No live animals or birds should be allowed inside or adjacent to the meat shops.

(8) Personnel Hygiene:

(a) Every person employed for meat handling at the meat shop shall be medically examined annually by aauthorized registered medical practitioner and examination shall include examination of sputum and x-ray of thechest for tuberculosis. The medical examination shall also include examination of stool for protozoal and helminthicinfestations for those parasites, which are transmitted by ingestion, and also for the presence of enteropathogenicEscherichia coli, Salmonella, Shigella spieces and Vibrio cholera.

(b) A certificate / records of medical fitness of all workers handling meat should be kept as a record in thepremises to be shown to any officer of the concerned Panchayats / Municipalities responsible for local administration/Corporation at the time of inspection.

(c) No worker suspected to be suffering from fever, vomiting, diarrhoea, typhoid, dysentery or boils, cuts andsores and ulcers (however small) shall be permitted to work in the meat shops.

(d) All the workers of the meat shop shall keep their finger nails short and clean and wash their hands withsoap or detergent and hot water before commencement of work and after each absence, especially after usingsanitary conveniences.

(e) Eating, spitting, nose cleaning or the use of tobacco in any form or chewing betel leaves shall be prohibitedwithin the premises of meat shop processing, packing and storage area of the unit. “No smoking “and “No Spitting“boards shall be prominently displayed in the shop.

(9) Sanitary Practices:

(a) The chopping block should be sanitized daily by covering its top with sea-salt, after cleaning it with hotwater at close of business activity.

(b) The floor should be washed with appropriate disinfectant / detergent / sanitizer at the start and close of thebusiness each working day.

(c) There should be high standard of cleanliness and tidiness in the working area of shop with no organic orother material lying on the floor.

Page 51: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

460 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(d) The refrigerated / freezing cabinet should be regularly cleaned and well maintained.

(e) Slaughtering of animal / birds inside the shop premises should be strictly prohibited.

(f) The carcasses shall not be allowed to be covered with wet-clothes.

(g) Wholesome meat obtained from the authorized slaughter house shall only be sold at the meat shops anda record thereof shall be kept in the premises to be shown to any officer of the concerned Panchayats / Municipalitiesresponsible for local administration Corporation at the time of inspection.

(h) Waste bins should be emptied, transported for disposal as per the arrangements made by the concernedPanchayats / Municipalities and waste bin / dhalau (burial pits) shall be treated daily with a disinfectant.

(i) The premises shall not be used for residential purposes nor shall it communicate with any residentialquarter. No personal belonging like clothing, bedding, shoes etc. shall be kept in the premises. Only dressedcarcasses of clean meat shall be stored at the premises.

(j) Hides, skins, hoofs, heads and unclean gut will not be allowed to be stored in the premises at any time.

(k) The chopping instruments should be cleaned with hot water at a temperature of 82 degree C.

(l) The preparation of food of any type inside the meat sale outlet should be strictly prohibited.

(m) The meat obtained from unauthorized sources or unstamped meat is liable to be confiscated and destroyed.

(n) Waste of the meat shop to be disposed of packed in heavy polythene bags in dhalaos (burial pits).

(10) Other Requirements

(a) The prepared meat shall be packed in waxed paper and then placed in polyethylene bags or packed directlyin bags made of food grade plastics.

(b) Failure to comply with any of these instructions may entail legal action against the defaulters, and evenresult in cancellation of licence by the appropriate authority of the concerned Panchayats/Municipalities/Corporation.

(c) No Objection Certificate from law and order point of view to be obtained from police department or theconcerned Panchayats/Municipalities/Corporation before grant of license for buffalo meat and pork shop.

(d) The concerned Panchayats/Municipalities responsible for local administration in the country shall appointqualified Veterinary staff for the meat inspection (Ante mortem and Post mortem inspection) or if regular staff cannotbe made available or deployed for the purpose shall make contractual arrangements for availing the services ofqualified Veterinary staff for meat inspection available with the Animal Husbandry Depts. of the concerned state/UTin the country.

(e) Veterinary health trade licence shall be granted subject to fulfillment of all the above technical andadministrative instructions in relation to the trade.

Part - V

Specific Hygienic and Sanitary Practices to be followed by Practices to be followed by Food Business Operatorsengaged in catering / food service establishments

In addition to Part-2 the Catering/ food Service establishment in which food is being handled, processed,manufactured, stored, distributed and ultimately sold to the customers and the persons handling them should conform tothe sanitary and hygienic requirement, food safety measures and other standard as specified below :

It includes premises where public is admitted for repose or for consumption of any food or drink or any placewhere cooked food is sold or prepared for sale. It includes:

(a) Eating Houses(b) Restaurants & Hotels(c) Snack Bars,(d) Canteens (Schools, Colleges, Office, Institutions)(e) Food Service at religious places(f) Neighbourhood Tiffin Services / dabba walas

Page 52: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 461

I. Good Manufacturing Practices for Whole Premises

(1) Food Preparation Areas

The following rules apply to rooms where food is prepared. There will be no smoke nuisance in the foodpreparation area. Wherever cooking or frying of any kind is being done, a chimney having appropriate suctioncapacity as per the size of the kitchen has to be installed prior to start of business.

(2) Hand washing facilities and toilets

(a) Adequate number of wash-hand basins made of porcelain/stainless steel shall be provided along withsoap to wash hands, with hot and cold running water, and materials for cleaning hands and drying them hygienically.Clean and dry towels shall be kept for the use of customers.

(b) Separate sinks must be provided, where necessary, for washing raw food and cleaning equipment.

(c) Sinks with a draining board, detergent and hot water shall be provided to ensure proper cleaning ofutensils, crockery and cutlery there will be a separate place for washing pots and pains.

(d) There must also be enough toilets and those must not lead directly into food areas.

(e) There shall be separate Sinks for washing utensils and raw food items

(2) Changing facilities:

Facilities for staff to change their clothes, where necessary must be provided.

II. Good Food Hygiene Practices

(1) Cleaning

(a) Food areas and equipment between different tasks, especially after handling raw food shall becleaned.

(b) Τhe surface shall be thoroughly cleaned in case if somebody spill some food / water / drink.

(c) A systematic cleaning schedule and instructions has to be developed by the FBO.

(d) Food handlers should strictly follow the systematic cleaning schedule to make sure thatsurfaces and equipment are cleaned when they need to be.

The schedule should include:

(i) what needs to be cleaned

(ii) how often it needs to be cleaned

(iii) how the cleaning should be done

Cleaning instructions should indicate:

(1) what cleaning products should be used

(2) how the products should be stored ( away from raw, cooked, packed food) and used

(3) how much they should be used or diluted

(4) how long that should be left in contact with the surface (following the manufacturer’sinstructions)

(2) Raw materials

(a) Raw materials shall be purchased from reliable and known dealers and checked for visibledeterioration & off- odour.

(b) Food ingredients shall be segregated from materials which are evidently unfit for humanconsumption.

(c) There should be no physical hazards and foreign body contamination.

(d) All raw materials should be checked & cleaned physically as well as in potable water thoroughly.

Page 53: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

462 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(e) Raw materials should be purchased in quantities that correspond to storage/ preservationcapacity.

(f) Packaged raw material must be checked for ‘expiry date’/ ‘best before’/ ‘use by’ date, packagingintegrity and storage conditions.

(g) Receiving temperature of potentially high risk food should be at or below 5 0C.

(h) Receiving temperature of frozen food should be -18 0C or below

(i) Raw paste, sauces etc. should be stored in properly covered containers made of food gradematerial and checked regularly for fungal growth, deterioration etc.

Preparation of fruits/ vegetables:

(a) Fruits and vegetables that have been protected from cross-contamination and properlyconservedshould be used.

(b) Fruits and vegetables should be used after removing parts or items in poor condition.

(c) Whole fruits and vegetables should be washed in potable water before being cut, mixed withother ingredients. Uncooked, ready-to-eat fruits & vegetables should be with 50 ppm chlorinated waterbefore cutting, peeling or serving.

(d) Fruits and vegetables should be peeled, squeezed and/or cut, as appropriate, with cleanequipment/utensils made of non-absorbent food grade materials.

(e) Previously prepared fruits/vegetables should be kept in clean and properly covered foodgrade containers under refrigeration or at a maximum temperature suitable for the product in question.

Preparation of Non-veg. Products:—

(a) Raw meat and processed meat should be separated from other foods; items and surfaces.(b) Separate items (e.g. cutting boards, dishes, knives) and preparation area for raw meats and

poultry and marine products should be used to avoid cross contamination of food.(c) Hands should be thoroughly washed before switching from preparing raw meat or poultry or

marine products to any other activity.(d) Ensure proper cooking of all non veg. products.(e) Used surfaces should be washed with antibacterial cleaning agent, rinsed properly with water

and sanitized after preparing raw meat/poultry.(f) Ensure that frozen products are thawed as per point no. 10 under high risk foods

(3) Cooking(a) The preparation/ processing/ cooking should be adequate to eliminate and reduce hazards to

an acceptable level which might have been introduced at the raw food level.(b) The preparation/ processing/ cooking methods should ensure that the foods are not re-

contaminated.(c) The preparation/ processing/ cooking of veg. & non-veg. products should be segregated.(d) Food should not be overcooked (e.g. charring) leading to chemical hazards.(e) Whenever cooking or reheating of food is done, it should be hot all the way through. It is

especially important to make sure that food is cooked thoroughly because there could be bacteria in themiddle of food.

(f) Re-use of cooking oil should be avoided

(4) Chilling

(a) Semi cooked or cooked dishes and other ready-to-eat foods such as prepared salads anddesserts having short shelf life should not be left standing around at room temperature.

(b) Chilled food on delivery should be cold enough.

Page 54: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 463

(c) Food items that need to be chilled should be put straight away into the fridge.

(d) Cooked food should be cooled as quickly as possible and then put it in the fridge.

(e) Chilled food should not be kept out of the fridge except for the shortest time possible duringpreparation.

(f) Fridge and display units should be cold enough and as per requirement.

(h) In practice, fridge should be set at 5ÚC to make sure that food is kept in chilled condition. Also,fridge and display units should be maintained in good working condition to avoid food spoilage andcontamination.

(5) Cross-contamination

Following things should be done to avoid cross - contamination.

(a) Raw food/ meat/poultry and ready-to-eat foods should be kept separate at all times.

(b) Hands should be thoroughly washed after touching raw meat/poultry.

(c) Work surfaces, chopping boards and equipments should be thoroughly cleaned beforethe preparing of food starts and after it has been used

(d) Separate chopping boards and knives for raw fruit/ vegetables/ meat/poultry and ready-to-eat food should be used.

(e) Raw meat/poultry below ready-to-eat food should be kept in the fridge.

(f) Separate fridge for raw meat/poultry should be kept.

(g) Staff should be made aware how to avoid cross-contamination.

III. Personal Hygiene

(1) High standards of personal hygiene should be maintained.

(2) All employees handling food should wash their hands properly:

(a) before preparing food

(b) after touching raw food or materials, specially meat/poultry or eggs

(c) after breaks

(d) after using the toilet

(e) after cleaning the raw materials or utensils / equipments

(3) Staff working with food must wear suitable clean clothes and where necessary, shall wear headcover, apron, musk mouth and use gloves etc.

(4) Street shoes inside the food preparation area should not be worn while handling & preparing food.

(5) Food handlers should ensure careful food handling & protect food from environmental exposure.

(6) Food handlers should avoid following practices while handling food:

(a) Chewing or smoking tobacco

(b) Chewing betel nut or gums

(c) Touching mouth, tongue, nose, eyes or other body parts

(d) Spitting, sneezing, coughing, etc.

(e) Touching ready-to-eat food with bare hands

(f) Handling food and money at same time

Page 55: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

464 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(g) not to wear watches or jewellery while preparing food

(7) All food handlers should be medically fit and free from diseases.

IV. Transportation & Handling of Food

(1) The vehicle/transportation being used to carry cooked/prepared/processed food should be clean,should be dedicated for this purpose and should not carry anything else.

(2) Time required for transportation should be minimum, to avoid microbial proliferation.

(3) Cooked food served hot should be kept at a temperature of at least 600 C to prevent microbial growth.

(4) Cooked food to be served cold should be kept below 50 C to prevent growth of pathogens. Otherwisetime of holding should be limited.

(5) All foods during transportation must be kept covered and in such a way as to limit pathogen growthor toxin formation by controlling time of transportation, exposure, temperature control and using safe waterfor cleaning etc.

(7) Handling of food should be minimal. It should be ensured that utensils, crockery, cutlery andspecially hands of the food handlers/seller are clean and sanitized.

(8) All surplus food and unused thawed food should be discarded.

(9) Food to be kept for cold storage should be distributed in small volumes to ensure uniform cooling.

(10) It is recommended that even dry, fermented and acidified foods should be stored in a cool and dryplace.

(11) All packaged food viz. sterilized milk, bottled beverages; canned foods should be stored properlyduring transportation to ensure that seals remain intact and undamaged.

V. STORAGE

(1) It is very important to store food properly for the purpose of food safety. Following things must beensured:

(a) Foods should be cooked, stored and kept at right temperature

(b) Raw meat/poultry should be stored separately from other foods

(c) Veg. foods should always be stored above non-veg. foods and cooked foods above uncookedfoods on separate racks in the refrigerator.

(d) Food after the ‘use by’ date should never be used, because it might not be safe to eat.

(e) Storage temperature of frozen food should be -18oC or below.

(f) Storage temperature of potentially high risk food should be at or below 5oC.

(g) Cooked food to be eaten later should be cooled quickly, and kept it in the fridge – it can bepracticed to put date on food packages or containers, using stickers or any other way of identification,before keeping inside the fridge to keep track of food prepared date wise and use accordingly tominimise wastage .

(h) Food with short shelf-life should be use first

(i) Storage instructions over food packaging should be followed.

(j) Dried foods (such as grains and pulses) should be stored off the floor, ideally in sealablecontainers, to allow proper cleaning and protection from pests.

Stock rotation

The rule is FIFO (first in, first out) to make sure that older food is used first. This will help toprevent wastage.

Page 56: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 465

VI. Special Requirements for High Risk Foods

This section deals selectively with few varieties of food which are high risk as per HACCP and may needspecial attention. The type of foods covered here are as follows:

(1) Cut fruits/salads, fresh juices and beverages(a) Fresh fruits /vegetables cut or juiced should be used immediately; however, short storage

should be only under refrigeration in sanitized and properly covered vessels.(b) Water used in beverages should be potable.(c) Ice used should be made of potable water only.(d) Food or beverages should not be stored in the same container used to store the ice

intended for consumption.(e) Juice concentrates must be checked regularly for any fungal growth / change of colour,

odour or gas formation in the bottle.(f) Juice dispensing machine should be cleaned and rinsed with water regularly.(g) Containers made of food grade material should be used for collecting juice.(h) Clean and intact utensils/crockery & cutlery / disposables should be used for serving.

(2) Confectionery products

(a) Prepared confectionery products should be kept in airtight containers and displayedhygienically.

(b) Cream to be used is stored covered under refrigeration.

(c) Finished products should be refrigerated with proper labels indicating date of expiry.

(d) Products should be properly wrapped/ packaged after proper cooling.

(e) Only permitted food additives (colour, preservatives, flavouring agents etc.) should beused.

(3) Meat, poultry & fish products

(a) Non veg. products/raw materials should be purchased (chilled products temperatureshould be at 50C or below and frozen products at -18 0C or below) from authorized/ licensedslaughter houses/vendors.

(b) Processing area should be cleaned and disinfected promptly.(c) Preparation and processing of meat, poultry and marine products should be separate.(d) Non-veg. products are washed with potable water before use.(e) Non-veg. products are cooked thoroughly (core temperature 750 C) for at least 15 seconds

or an effective time/temperature control e.g. 65 0C for 10 minutes, 70 0C for 2 minutes.(f) Non-veg. products should be stored covered in refrigerator below the veg. products.(g) Raw and cooked products should be stored physically separated with cooked products

at the top.(h) All refuse/waste should be promptly removed from preparation area.

(4) Milk & dairy products

(a) All equipments and utensils should be thoroughly washed and rinsed with potablewater before starting of work and at the end.

(b) All mechanical equipments should be routinely cleaned, checked and maintained.

(c) All products should be routinely checked for spoilage/contamination and shelf life.

(d) Any spoiled/contaminated product should be promptly removed and discarded.

Page 57: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

466 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(e) Milk should be received in clean and hygienic conditions at temperature below 50C.

(f) Milk and milk products should be used immediately or pasteurized and refrigerated.

(5) Water based chutneys, sauces etc.

(a) All fruits/vegetables should be washed properly before processing.(b) Clean and disinfected chopping boards/grinding stone/machine should be used.(c) Personal hygiene of food handlers need to be ensured.(d) Water used in the chutneys should be safe and potable.(e) Only permitted food additives should be used, if required, and in added in recommended

quantities only.(f) Spoiled products should be discarded immediately after confirmation of spoilage (change

in colour/ texture/ odour).(g) Sauces and chutneys should be packed/stored in appropriate manner in clean and

hygienic containers.(h) Clean and intact containers should be used for storing sauces and chutneys.(i) Sauces and chutneys should be stored in refrigerator when not in use.(j) Perishable/uncooked chutneys should be consumed immediately.

(6) Foods transported to point of sale from the point of cooking

(a) Food should be reheated up to 700 C before consumption.

(b) Food should be consumed within 4 hours of reheating.

(7) Foods with Gravy

(a) Food products should not be stored at room temperature for more than 2 hours duringdisplay or sale.

(b) For prolonged storage, foods should be stored in refrigerators or kept for hot holding ator above 60 0C.

(c) No water should be added after cooking/reheating/boiling.

(8) Fried Foods

(a) Proper quality / branded oils/fats should be used for food preparation, frying etc.

(b) Use packaged oil only.

(c) Use of oils with high trans fats (like vanaspati) should be avoided as far as possible.

(d) Re-heating and reuse of oil should be avoided as far as possible. Therefore, avoid havingleftover oil wherever possible.

(9) Post Cooked Mixing

(a) Ingredients added to the cooked food should be thoroughly washed/ cleaned.

(b) After cooking or post cooked mixing, the food should be used immediately.

(c) Garnishes etc., if added should be prepared using fresh, thoroughly washed and freshly cutvegetables and used immediately.

(10) Thawing of Frozen Products

(a) Frozen products should be thawed in refrigerator/microwave/convection oven or under runningpotable water well before cooking.

(b) Only required portion of the food should be thawed at a time.

(c) Thawed products should be used immediately and not refrozen or kept in chiller.

Page 58: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 467

CHAPTER 4PACKAGING AND LABELLING REGULATIONS

Part 4.1: Packaging

Regulation 4.1.1: General Requirements

(1) A utensil or container made of the following materials or metals, when used in the preparation, packagingand storing of food shall be deemed to render it unfit for human consumption:—

(a) containers which are rusty;

(b) enameled containers which have become chipped and rusty;

(c) Copper or brass containers which are not properly tinned

(d) containers made of aluminium not conforming in chemical composition to IS:20 specification for CastAluminium & Aluminium Alloy for utensils or IS:21 specification for Wrought Aluminium and AluminiumAlloy for utensils

(2) Containers made of plastic materials should conform to the following Indian Standards Specification, usedas appliances or receptacles for packing or storing whether partly or wholly, food articles namely :—

(i) IS : 10146 (Specification for Polyethylene in contact with foodstuffs);

(ii) IS : 10142 (Specification for Styrene Polymers in contact with foodstuffs);

(iii) IS : 10151 (Specification for Polyvinyl Chloride (PVC), in contact with foodstuffs);

(iv) IS : 10910 (Specification for Polypropylene in contact with foodstuffs)

(v) IS : 11434 (Specification for Ionomer Resins in contact with foodstuffs)

(vi) IS: 11704 Specification for Ethylene Acrylic Acid (EAA) copolymer.

(vii) IS: 12252 - Specification for Poly alkylene terephathalates (PET)

(viii) IS: 12247 - Specification for Nylon 6 Polymer;

(ix) IS: 13601 - Ethylene Vinly Acetate (EVA)

(x) IS: 13576 - Ethylene Metha Acrylic Acid (EMAA)(xi) Tin and plastic containers once used, shall not be re-used for packaging of edible oils and fats;

PROVIDED that utensils or containers made of copper though not properly tinned, may be used for thepreparation of sugar confectionery or essential oils and mere use of such utensils or containers shall not bedeemed to render sugar confectionery or essential oils unfit for human consumption.

(3) General packaging requirements for Canned products

(i) All containers shall be securely packed and sealed

(ii) The exterior of the cans shall be free from major dents, rust, perforations and seam distortions.

(iii) Cans shall be free from leaks.

Regulation 4.1.2: Product specific requirements

(1) Packaging requirements for Milk and Milk Products

(a) Bottling or filling of containers with heat-treated milk and milk product shall be carried out mechanicallyand the sealing of the containers shall be carried out automatically.

(b) Wrapping or packaging may not be re-used for dairy products, except where the containers are of atype which may be re-used after thorough cleaning and disinfecting.

(c) Sealing shall be carried out in the establishment in which the last heat-treatment of drinking milk orliquid milk-base products has been carried out, immediately after filling, by means of a sealing device whichensures that the milk is protected from any adverse effects of external origin on its characteristic. The sealing

Page 59: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

468 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

device shall be so designed that once the container has been opened, the evidence of opening remains clearand easy to check.

(d) Immediately after packaging, the dairy products shall be placed in the rooms provided for storage.

(2) Packaging requirements for Edible oil/ fat:

Tin Plate used for the manufacture of tin containers for packaging edible oils and fats shall conform tothe standards of prime grade quality contained in B.I.S. Standards No. 1993 or 13955 or 9025 or 13954 asamended from time to time and in respect of Tin containers for packaging edible oils and fats shall conform toIS No. 10325 or 10339 as amended from time to time.

(3) Packaging requirements for Fruits and Vegetables Products

(i) Every container in which any fruit product is packed shall be so sealed that it can not be openedwithout destroying the licensing number and the special identification mark of the manufacture to be displayedon the top or neck of the bottle.

(ii) For Canned fruits, juices and vegetables, sanitary top cans made up of suitable kind of tin platesshall be used

(iii) For Bottled fruits, juices and vegetables, only bottles/ jars capable of giving hermetic seal shall beused

(iv) Juices, squashes, crush, cordials, syrups, barley waters and other beverages shall be packed inclean bottles securely sealed. These products when frozen and sold in the form of ice shall be packed insuitable cartons. Juices and Pulps may be packed in wooden barrels when sulphited.

(v) For packing Preserves, Jams, Jellies, and Marmalades, new cans, clean jars, new canisters, bottles,chinaware jars of aluminium containers may be used for packing these products and it shall be securelysealed.

(vi) For Pickles, clean bottles, jars, wooden casks, tin containers covered from inside with polythenelining of 250 gauge or suitable lacquered cans shall be used.

(vii) For Tomato Ketchups and Sauces, clean bottles shall be used. If acidity doesnot exceed 0.5% asacetic acid, open top sanitary cans may also be used.

(viii) Candied fruits and peels and dried fruits and vegetables can be packed in paper bags, cardboardor wooden boxes, new tins, bottles, jars, aluminium and other suitable approved containers.

(ix) Fruits and Vegetable products can also be packed in aseptic and flexible packaging material havinggood grade quality conforming to the standards laid down by BIS.

(4) Packaging requirements for Canned Meat Products

(i) New sanitary top cans made from suitable kind of tin plate shall be used. The cans shall be lacqueredinternally; they shall be sealed hermetically after filling. The lacquer used shall be sulphur resistant and shallnot be soluble in fat or brine.

(ii) Cans used for filling pork luncheon meat shall be coated internally with edible gelatin, lard or linedwith vegetable parchment paper before being filled.

(iii) Meat products packed in hermetically sealed containers shall be processed to withstand spoilageunder commercial conditions of storage and transport.

(5) Packaging requirements for Drinking Water (Both Packaged and Mineral Water)

It shall be packed in clean, hygienic, colourless, transparent and tamperproof bottles/containers madeof polyethylene (PE) (conforming to IS:10146 or polyvinyl chloride (PVC) conforming to IS : 10151 or polyalkyleneterephthalate (PET and PBT) conforming to IS : 12252 or polypropylene conforming to IS : 10910 or foodgradepolycarbonate or sterile glass bottles suitable for preventing possible adulteration or contamination of thewater.

All packaging materials of plastic origin shall pass the prescribed overall migration and colour migrationlimits

Page 60: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 469

PART 4.2: Labelling

Regulation 4.2.1: General Requirements

(1) Every prepackaged food shall carry a label containing information as required under these regulationsunless otherwise provided;

(2) Language of the particulars or declaration of the label:

The particulars of declaration required under these Regulations to be specified on the label shall be inEnglish or Hindi in Devnagri script:

Provided that nothing herein contained shall prevent the use of any other language in addition tothe language required under this regulation.

(3) Pre-packaged food shall not be described or presented on any label or in any manner that is false,misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect;

(4) Label in pre-packaged foods shall be applied in such a manner that they will not become separated from thecontainer;

(5) Contents on the label shall be clear, prominent, indelible and readily legible by the consumer under normalconditions of purchase and use;

(6) Where the container is covered by a wrapper, the wrapper shall carry the necessary information or the labelon the container shall be readily legible through the outer wrapper and not obscured by it;

Regulation 4.2.2: Labelling of Pre-packaged Foods

(1) Every package of food shall carry the following information on the label.

(2) The Name of Food: The name of the food shall include trade name or description of food contained in thepackage.

(3) List of Ingredients: Except for single ingredient foods, a list of ingredients shall be declared on the labelin the following manner:—

(a) The list of ingredients shall contain an appropriate title, such as the term “Ingredients”;

(b) The name of Ingredients used in the product shall be listed in descending order of their compositionby weight or volume, as the case may be, at the time of its manufacture;

(c) A specific name shall be used for ingredients in the list of Ingredients;

Provided that for Ingredients falling in the respective classes, the following class titles may be used,namely:–

Name of the classes Class names

Edible vegetable oils/ Edible vegetable oil/

Edible vegetable fat Edible vegetable fat or both hydrogenatedor Partially hydrogenated oil

Animal fat / oil other than milk fat Give name of the source of fat, Pork fat, lardand beef fat or extracts thereof shall bedeclared by specific names

Starches, other than chemically modified starches Starch

All species of fish where the fish constitutes an ingredient of another Fishfood and provided that the labelling and presentation of such fooddoes not refer to a species of fish

All types of poultry meat where such meat constitutes an ingredient Poultry meatof another food and provided that the labelling and presentation ofsuch a food does not refer to a specific type of poultry meat

Page 61: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

470 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Name of the classes Class names

All types of cheese where cheese or mixture of cheeses constitutes Cheesean ingredient of another food and provided that the labelling andpresentation of such food does not refer to a specific type of cheese

All spices and condiments and their extracts Spices and condiments or mixed spices/condiments as appropriate

All types of gum or preparations used in the manufacture of gum Gum Basebase for chewing gum

Anhydrous dextrose and dextrose monohydrate Dextrose or Glucose

All types of Caseinates Caseinates

Press, expeller or refined cocoa butter Cocoa butter

All crystallized fruit Crystallized fruit

All milk and milk products derived solely from milk Milk solids

Cocoa bean, Coconib, Cocomass, Cocoa press cakes, Cocoa powder Cocoa solids(Fine/Dust)

Provided further that pork fat, lard and beef fat or extract thereof shall be declared by their specificnames

(d) Where an ingredient itself is the product of two or more ingredients, such a compound ingredientsshall be declared in the list of ingredients, and shall be accompanied by a list, in brackets, of its ingredients indescending order of weight or volume, as the case may be:

Provided that where a compound ingredient, constitutes less than five percent of the food, the list ofingredients of the compound ingredient, other than food additive, need not to be declared;

(e) Added water shall be declared in the list of ingredients except in cases where water forms part of aningredient, such as, brine, syrup or broth, used in the compound food and so declared in the list of ingredients:

Provided that water or other volatile ingredients evaporated in the course of manufacture need not bedeclared;

Provided further that in the case of dehydrated or condensed food, which are intended to be reconstitutedby addition of water, the ingredients in such reconstituted food shall be declared in descending order ofweight or volume as the case may be, and shall contain a statement such as “Ingredients of the product whenprepared in accordance with the directions on the label”;

(f) Every package of food sold as a mixture or combination shall disclose the percentage of the ingredientused at the time of the manufacture of the food (including compound ingredients or categories of ingredients),if such ingredient–

(i) is emphasised as present on the label through words or pictures or graphics; or(ii) is not within the name of the food but, is essential to characterise the food and is expected to

be present in the food by consumers, if the omission of the quantitative ingredient declaration willmislead or deceive the consumer.Provided that where the ingredient has been used as flavouring agent, the disclosure of such ingredient

is not required:Provided further that where the drained net weight is indicated on the label as required or in case

of such food products where specific provisions are stipulated under these Regulations or where apictorial representation of a serving suggestion is made for consumer information and use, the disclosureof such ingredient is not required.

Provided further that in case of any bottle containing liquid milk or liquid beverage having milk asan ingredient, soft drink, carbonated water or ready-to-serve fruit beverages, the declarations withregard to addition of fruit pulp and fruit juice shall invariably appear on the body of the bottle.

Page 62: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 471

(4) Nutritional information – Nutritional Information or nutritional facts per 100 gm or 100ml or per serving ofthe product shall be given on the label containing the following:—

(i) energy value in kcal;

(ii) the amounts of protein, carbohydrate (specify quantity of sugar) and fat in gram (g);

(iii) the amount of any other nutrient for which a nutrition or health claim is made:

Provided that where a claim is made regarding the amount or type of fatty acids or the amount ofcholesterol, the amount of saturated fatty acids, monounsaturated fatty acids and polyunsaturatedfatty acids in gram (g) and cholesterol in milligram (mg) shall be declared, and the amount of trans fattyacid in gram (g) shall be declared in addition to the other requirement stipulated above;

Wherever, numerical information on vitamins and minerals is declared, it shall be expressed inmetric units;

Where the nutrition declaration is made per serving, the amount in gram (g) or milliliter (ml) shallbe included for reference beside the serving measure;

Provided that –

(i) the nutritional information may not be necessary, in case of foods such as raw agriculturalcommodities, like, wheat, rice, cereals, spices, spice mixes, herbs, condiments, table salt, sugar,jaggery, or non –nutritive products, like, soluble tea, coffee, soluble coffee, coffee-chicory mixture,packaged drinking water, packaged mineral water, alcoholic beverages or fruit and vegetables,processed and pre- packaged assorted vegetables, fruits, vegetables and products that compriseof single ingredient, pickles, papad, or foods served for immediate consumption such as served inhospitals, hotels or by food services vendors or halwais, or food shipped in bulk which is not forsale in that form to consumers.

(ii) The compliance to quantity of declared nutrients on the label shall be according to theestablished practices.

Explanation – For the purpose of this provision, at the time of analysis, due consideration, basedon shelf-life, storage, and inherent nature of the food shall be kept in view in case of quantity declarednutrients;

(iii) The food, in which hydrogenated vegetable fats or bakery shortening is used shalldeclare on the label that ‘hydrogenated vegetable fats or bakery shortening used- contains transfats;

Provided further that, a health claim of ‘trans fat free’ may be made in cases where the trans fat isless than 0.2 gm per serving of food and the claim ‘saturated fat free’ may be made in cases where thesaturated fat does not exceed 0.1 gm per 100 gm or 100 ml of food.

For the purpose of Regulation 4.2.2 (4);

(i) “Health claims” means any representation that states, suggests or implies that a relationship existsbetween a food or a constituent of that food and health and include nutrition claims which describe thephysiological role of the nutrient in growth, development and normal functions of the body, other functionalclaims concerning specific beneficial effect of the consumption of food or its constituents, in the context ofthe total diet, on normal functions or biological activities of the body and such claims relate to a positivecontribution to health or to the improvement of function or to modifying or preserving health, or disease riskreduction claim relating to the consumption of a food or food constituents, in the context of the total diet, tothe reduced risk of developing a disease or health related condition;

(ii) “Nutrition claim” means any representation which states, suggests or implies that a food hasparticular nutritional properties which are not limited to the energy value but include protein, fat andcarbohydrates, vitamins and minerals;

(iii) “Risk reduction” in the context of health claims means significantly altering a major risk factor fora disease or health-related condition;

Page 63: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

472 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided Further that in the case of returnable new glass bottle manufactured and used for packing ofsuch beverages on or after 19th March 2009 shall carry these declarations on its body”.

(5) Veg/ Non veg declaration –

(i) Every package of “Non Vegetarian” food shall bear a declaration to this effect made by asymbol and colour code as stipulated below to indicate that the product is Non-Vegetarian Food. Thesymbol shall consist of a brown colour filled circle having a diameter not less than the minimum sizespecified in the Table mentioned in the Regulation 4.2.2 (5) (iv), inside a square with brown outlinehaving sides double the diameter of the circle as indicated below :

Brown colour

(ii) Where any article of food contains egg only as Non-Vegetarian ingredient, the manufacturer,or packer or seller may give declaration to this effect in addition to the said symbol.

(iii) Every package of Vegetarian Food shall bear a declaration to this effect by a symbol andcolour code as stipulated below for this purpose to indicate that the product is Vegetarian Food. Thesymbol shall consist of a green colour filled circle, having a diameter not less than the minimum sizespecified in the Table below, inside the square with green outline having size double the diameter of the

circle, as indicated below : Green colour

(iv) Size of the logo

Sl No. Area of principal display panel Minimum size of diameters in mm

1. Upto 100 cms. Square 3

2. Above 100 cms. Square upto 500 cms square 4

3. Above 500 cms square upto 2500 cms square 6

4. Above 2500 cms. Square 8

(a) the symbol shall be prominently displayed

(i) on the package having contrast background on principal display panel

(ii) just close in proximity to the name or brand name of the product

(iii) on the labels, containers, pamphlets, leaflets, advertisements in any media

Provided also that the provisions of Regulation 4.2.2(4) shall not apply in respect of mineralwater or packaged drinking water or carbonated water or liquid and powdered milk.

(6) Declaration of Food Additives:

(i) For food additives falling in the respective classes and appearing in lists of food additives permittedfor use in foods generally, the following class titles shall be used together with the specific names or recognizedinternational numerical identifications:

Acidity Regulator, Acids, Anticaking Agent, Antifoaming Agent, Antioxidant, Bulking Agent,Colour, Colour Retention Agent, Emulsifier, Emulsifying Salt, Firming Agent, Flour Treatment Agent,Flavour Enhancer, Foaming Agent, Gelling Agent, Glazing Agent, Humectant, Preservative, Propellant,Raising Agent, Stabilizer, Sweetener, Thickener:

(ii) Addition of colours and/or Flavours—

(a) Extraneous addition of colouring matter to be mentioned on the label – Where an extraneouscolouring matter has been added to any article of food, there shall be displayed one of the followingstatements in capital letters, just beneath the list of the ingredients on the label attached to any packageof food so coloured, namely:

Page 64: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 473

CONTAINS PERMITTED NATURAL COLOUR(S)

OR

CONTAINS PERMITTED SYNTHETIC FOOD COLOUR(S)

OR

CONTAINS PERMITTED NATURAL AND SYNTHETIC FOOD COLOUR(S)

Note: Provided that where such a statement is displayed, the colour used in the product need not bementioned in the list of ingredients.

(b) Extraneous addition of flavouring agents to be mentioned on the label—Where an extraneousflavouring agent has been added to any article of food, there shall be written just beneath the list ofingredients on the label attached to any package of food so flavoured, a statement in capital letters asbelow :

CONTAINS ADDED FLAVOUR (specify type of flavouring agent as per Regulation 6.1.9(1))

(c) In case both colour and flavour are used in the product, one of the following combinedstatements in capital letters shall be displayed, just beneath the list of ingredients on the label attachedto any package of food so coloured and flavoured, namely :—

CONTAINS PERMITTED NATURAL C0LOUR(S) AND ADDED FLAVOUR(S)OR

CONTAINS PERMITTED SYNTHETIC FOOD COLOUR(S) AND ADDED FLAVOUR(S)OR

CONTAINS PERMITTED NATURAL AND SYNTHETIC FOOD COLOUR(S) AND ADDED FLAVOUR(S)

Provided that in case of artificial flavouring substances, the label shall declare the common name of theflavours, but in case of the natural flavouring substances or nature identical flavouring substances, theclass name of flavours shall be mentioned on the label and it shall comply with the requirement of labeldeclaration as specified under the Regulation 4.2.2 (6) (ii)

(d) When statement regarding addition of colours and/or flavours is displayed on the label inaccordance with Regulation 4.2.2(6)(ii) and Regulation 6.2.1 of these Regulations, addition of suchcolours and/or flavours need not be mentioned in the list of ingredients.

Note: — In addition to above statement, the common name or class name of the flavour shall also bementioned on label.

Provided further that when combined declaration of colours and flavours are given, the internationalnumerical identification number of colours used shall also be indicated either under the list of ingredients oralong with the declaration.

Provide also further that every package of synthetic food colours preparation and mixture shall bear alabel upon which is printed a declaration giving the percentage of total dye content

(7) Name and complete address of the manufacturer

(i) The name and complete address of the manufacturer and the manufacturing unit if these are locatedat different places and in case the manufacturer is not the packer or bottler, the name and complete address ofthe packing or bottling unit as the case may be shall be declared on every package of food;

(ii) Where an article of food is manufactured or packed or bottled by a person or a company under thewritten authority of some other manufacturer or company, under his or its brand name, the label shall carry thename and complete address of the manufacturing or packing or bottling unit as the case may be, and also thename and complete address of the manufacturer or the company, for and on whose behalf it is manufacturedor packed or bottled;

(iii) Where an article of food is imported into India, the package of food shall also carry the name andcomplete address of the importer in India.

Page 65: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

474 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided Further that where any food article manufactured outside India is packed or bottled in India,the package containing such food article shall also bear on the label, the name of the country of origin of thefood article and the name and complete address of the importer and the premises of packing or bottling inIndia.

(8) Net content

(i) Net Content by weight or volume or number, as the case may be, shall be declared on every packageof food; and

(ii) In addition to the declaration of net contents, a food packed in a liquid medium shall carry adeclaration of the drained weight of the food.

Explanation 1.- For the purposes of this requirement the expression “liquid medium” include water,aqueous solutions of sugar and salt, fruit and vegetable juices or vinegar, either singly or in combination.

Explanation2.- In declaring the net quantity of the commodity contained in the package, the weight ofthe wrappers and packaging materials shall be excluded:

(iii) Where a package contains a large number of small items of confectionery, each of which is separatelywrapped and it is not reasonably practicable to exclude from the net weight of the commodity, the weight ofsuch immediate wrappers of all the items of the confectionery contained in the package, the net weightdeclared on the package containing such confectionary or on the label thereof may include the weight of suchimmediate wrapper if the total weight of such immediate wrapper does not exceed –

(a) eight per cent. Where such immediate wrapper is a waxed paper or other paper with wax oraluminium foil under strip; or

(b) six per cent. In case of other paper of the total net weight of all the items of confectionerycontained in the package minus the weight of immediate wrapper.

(9) Lot/Code/Batch identification

A batch number or code number or lot number which is a mark of identification by which the food can betraced in the manufacture and identified in the distribution, shall be given on the label.

Provided that in case of packages containing bread and milk including sterilised milk, particulars underthis clause shall not be required to be given on the label.

(10) Date of manufacture or packing.—

The date, month and year in which the commodity is manufactured, packed or pre-packed, shall begiven on the label:

Provided that the month and the year of manufacture, packing or pre-packing shall be given if the“Best Before Date” of the products is more than three months:

Provided Further that in case any package contains commodity which has a short shelf lifeof less than three months, the date, month and year in which the commodity is manufactured orprepared or pre-packed shall be mentioned on the label.

(11) Best Before

(i) the month and year in capital letters upto which the product is best for consumption, in the followingmanner, namely:—

“BEST BEFORE ....... MONTHS AND YEAR

OR

“BEST BEFORE .......... MONTHS FROM PACKAGING

OR

“BEST BEFORE ............MONTHS FROM MANUFACTURE

(Note: — blank be filled up)

Page 66: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 475

(ii) In case of package or bottle containing sterilised or Ultra High Temperature treated milk, soya milk,flavoured milk, any package containing bread, dhokla, bhelpuri, pizza, doughnuts, khoa, paneer, or anyuncanned package of fruits, vegetable, meat, fish or any other like commodity, the declaration be made asfollows:—

“BEST BEFORE ……….DATE/MONTH/YEAR”

OR

“BEST BEFORE........DAYS FROM PACKAGING”

OR

“BEST BEFORE …….. DAYS FROM MANUFACTURE”

Note:

(a) blanks be filled up

(b) Month and year may be used in numerals

(c) Year may be given in two digits

(iii) On packages of Aspartame, instead of Best Before date, Use by date/recommended last consumptiondate/expiry date shall be given, which shall be not more than three years from the date of packing;

(iv) In case of infant milk substitute and infant foods instead of Best Before date, Use by date/recommended last consumption date/expiry date shall be given,

Provided FURTHER that the declaration of best before date for consumption shall not be applicable to

(i) wines and liquors

(ii) alcoholic beverages containing 10 percent or more by volume of alcohol.

Provided further that all the above provisions except net weight/net content, nutritional information,manufacturer’s name and address, date of manufacture and “best before” shall not apply in respect ofcarbonated water (plain soda and potable water impregnated with carbon dioxide under pressure) packed inreturnable glass bottles

(12) Country of origin for imported food:

(i) The country of origin of the food shall be declared on the label of food imported into India.

(ii) When a food undergoes processing in a second country which changes its nature, the country inwhich the processing is performed shall be considered to be the country of origin for the purposes oflabelling.

(13) Instructions for use:

(i) Instructions for use, including reconstitution, where applicable, shall be included on the label, ifnecessary, to ensure correct utilization of the food.

Part 4.3: Manner of declaration

Regulation 4.3.1: General Conditions

(1) Any information or pictorial device written, printed, or graphic matter may be displayed in the labelprovided that it is not in conflict with the requirements of these Regulations.

(2) Every declaration which is required to be made on package under these regulations shall be

(i) Legible and prominent, definite, plain and unambiguous

(ii) Conspicuous as to size number and colour

Page 67: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

476 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(iii) as far as practicable, in such style or type of lettering as to be boldly, clearly and conspicuouslypresent in distinct contrast to the other type, lettering or graphic material used on the package, and shall beprinted or inscribed on the package in a colour that contrasts conspicuously with the background of the label

Provided that —

(a) Where any label information is blown, formed or moulded on a glass or plastic surface or where suchinformation is embossed or perforated on a package, that information shall not be required to be presented incontrasting colours:

(b) Where any declaration on a package is printed either in the form of a handwriting or hand script,such declaration shall be clear, unambiguous and legible.

(3) No declaration shall be made so as to require it to be read through any liquid commodity contained in thepackage.

(4) Where a package is provided with an outside container or wrapper, such container or wrapper shall alsocontain all the declarations which are required to appear on the package except where such container or wrapperitself is transparent and the declarations on the package are easily readable through such outside container orwrapper.

(5) Labels not to contain false or misleading statements: A label shall not contain any statement, claim,design, device, fancy name or abbreviation which is false or misleading in any particular concerning the foodcontained in the package, or concerning the quantity or the nutritive value or in relation to the place of origin of thesaid food:

Provided that this regulation shall not apply in respect of established trade or fancy names of confectionery,biscuits and sweets, such as, barleysugar or in respect of aerated waters, such as, Ginger Beer or Gold-Spot or anyother name in existence in international trade practice.

Regulation 4.3.2 Principal display panel: The information required under these Regulations shall be given onthe principal display panel of the package or container and such information may be given in the following manner.

(a) All information should be grouped together and given at one place.

Or

The pre-printed information be grouped together and given in one place and

(b) Online information or those not pre-printed be grouped together in another place.

(1) Area of the principal display panel

The area of principal Display panel shall not be less than —

(a) In the case of a rectangular container, forty percent of the product of height and width of the panelof such container having the largest area;

(b) In case of cylindrical or nearly cylindrical, round or nearly round, oval or nearly oval container,twenty percent of the product of the height and average circumference of such container; or

(c) In the case of container of any other shape, twenty percent of the total surface area of the containerexcept where there is label, securely affixed to the container, such label shall give a surface area of not lessthan ten percent of the total surface area of the container.

Provided that in the case of package having a capacity of five cubic centimeters or less, the principal displaypanel may be card or tape affixed firmly to the package or container and bearing the required information under theseRegulations.

Regulation 4.3.3 The height of numeral in the declaration

(i) The height of any numeral required under these regulations, on the principal display panel shall notbe less than—

(a) as shown in Table - I below, if the net quantity is declared in terms of weight or volumem and(b) as shown in Table II below, if the net quantity is declared in terms of length, area or number.

Page 68: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 477

TABLE – IWhen net quantity is in weight or volume

Sl. Weight/volume Minimum height of numeral in mmNo. Normal case When blown, formed Moulded,

or perforated on container

1. Upto 50g/ml 1 2

2. Above 50g/ml upto 200g/ml 2 4

3. Above 200 g/ml upto 1 kg/litre 4 6

4. Above 1 kg/litre 6 8

TABLE – IIWhen net quantity is in length, area, number

Sl. Area of principal display panel Minimum height of numeral in mmNo. Normal case When blown, formed Moulded,

or perforated on container

1. Upto 100 cms square 1 2

2. Above 100 cms. Square upto 500 cms. Square 2 4

3 Above 500 cms. Square upto 2500 cms. Square 4 6

4. Above 2500 cms. Square 6 8

(ii) The height of letters in the declaration under Part 4.2 shall not be less than 1 mm. When blown,formed, moulded, embossed or perforated, the height of letters shall not be less than 2mm.

Provided that the width of the letter or numeral shall not be less than one-third of its height, but thisproviso shall not apply in the case of numeral “1” and letters i, I& l:

Provided further that in case of label declarations required under Part 4.4 except in case declarationspecifying instructions for use or preparation of the product, the size of letters shall not be less than 3mm.

Part 4.4: Specific Requirements/ Restrictions on manner of labelling

Regulation 4.4.1: Labelling of infant milk substitute and infant food

(1) An article of infant milk substitutes /infant foods, whose standards are not prescribed under Chapter 5,shall be manufactured for sale, exhibited for sale or stored for sale only after obtaining the approval of such articlesof food and its label from the Authority

(2) Without prejudice to any other provisions relating to labelling requirements contained in these regulations,every container of infant milk substitute or infant food or any label affixed thereto shall indicate in a clear, conspicuousand in an easily readable manner, the words “IMPORTANT NOTICE” in capital letters and indicating thereunder thefollowing particulars, namely:—

(i) a statement “MOTHER’S MILK IS BEST FOR YOUR BABY” in capital letters. The types of lettersused shall not be less than five millimeters and the text of such statement shall be in the Central Panel of everycontainer of infant milk substitute or infant food or any label affixed thereto. The colour of the text printed orused shall be different from that of the background of the label, container as the case may be. In case of infantfood, a statement indicating “infant food shall be introduced only (after the age of six months and upto the ageof two years)” shall also be given;

(ii) a statement that infant milk substitute or infant food should be used only on the advice of a healthworker as to the need for its use and the proper method of its use;

(iii) a warning that infant milk substitute or infant food is not the sole source of nourishment of an infant;

Page 69: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

478 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(iv) a statement indicating the process of manufacture (e.g spray dried) except in case of infant foods,instruction for appropriate and hygienic preparation including cleaning of utensils, bottles and teats andwarning against health hazards of inappropriate preparations, as under;

“Warning/ caution-Careful and hygienic preparation of infant foods/infant milk substitute is mostessential for health. Do not use fewer scoops than directed since diluted feeding will not provideadequate nutrients needed by your infant. Do not use more scoops than directed since concentratedfeed will not provide the water needed by your infant”.

(v) the approximate composition of nutrients per 100 gms. of the product including its energy value inKilo Calories/Joules;

(vi) the storage condition specifically stating “store in a cool and dry place in an air tight container” orthe like (after opening use the contents within the period mentioned or the expiry date whichever is earlier);

(vii) the feeding chart and directions for use and instruction for discarding leftover feed;

(viii) Instruction for use of measuring scoop (level or heaped) and the quantity per scoop (scoop to begiven with pack);

(ix) indicating the Batch No. Month and Year of its manufacture and expiry date

(x) the protein efficiency ratio (PER) which shall be minimum 2.5 if the product other than infant milksubstitute is claimed to have higher quality protein;

(xi) the specific name of the food additives, if permitted, shall be declared in addition to appropriate classnames.

(3) No containers or label referred to in Regulation 4.4.1(2) relating to infant milk substitute or infant foodshall have a picture of infant or women or both. It shall not have picture or other graphic materials or phrasesdesigned to increase the saleability of the infant milk substitute or infant food. The terms “Humanised” or“Maternalised” or any other similar words shall not be used. The Package and/or any other label of infant milksubstitute or infant food shall not exhibit the words, “Full Protein Food”, “energy Food”, Complete food” or “HealthFood” or any other similar expression.

(4) The containers of infant milk substitute meant for (premature baby (born before 37 weeks)/low birth weightinfant (less than 2500gm) or labels affixed thereto shall indicate the following additional information, namely:—

(i) the words [PREMATURE BABY (BORN BEFORE 37 WEEKS) LOW BIRTH WEIGHT (LESS THAN2.5 KG] in capital letters along with the product name in central panel;

(ii) a statement “the low birth weight infant milk substitute shall be withdrawn under medical advice assoon as the mother’s milk is sufficiently available’; and

(iii) a statement “TO BE TAKEN UNDER MEDICAL ADVICE” in capital letters.

(5) The product which contains neither milk nor any milk derivatives shall be labeled “contains no milkor milk product” in conspicuous manner.

(6) The container of infant milk substitute for lactose or lactose and sucrose intolerant infants or labelaffixed thereto shall indicate conspicuously “LACTOSE-FREE or SUCROSE-FREE or LACTOSE and SUCROSE-FREE” in capital letters and statement “TO BE TAKEN UNDER MEDICAL ADVICE” and shall also bear thefollowing statements, namely:—

“Lactose free Infant Milk Substitute should only be used in case of diarrhea due to lactoseintolerance.

The lactose free/sucrose free Infant Milk Substitute should be withdrawn if there is no improvementin symptoms of intolerance”.

(7) The container of infant milk substitute meant for infants with allergy to cow’s /buffalo’s milk proteinor soy protein or label affixed thereto shall indicate conspicuously “HYPOALLERGENIC FORMULA” incapital letters and statement “TO BE TAKEN UNDER MEDICAL ADVICE”.

Page 70: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 479

(8) Declaration to be surrounded by line:

There shall be a surrounding line enclosing the declaration where the words “unsuitable forbabies” are required to be used.

(i) Distance of surrounding line:

The distance between any part of the words “unsuitable for babies” surrounding theline enclosing these words shall not be less than 1.5 mm.

Regulations 4.4.2: Labelling of edible oils and fats

(1) The package, label or the advertisement of edible oils and fats shall not use the expressions “Super-Refined”, “Extra-Refined”, “Micro-Refined”, “Double-Refined”, Ultra-Refined”, “Anti-Cholesterol”, CholesterolFighter”, “Soothing to Heart”, “Cholesterol Friendly”, “Saturated Fat Free” or such other expressions which are anexaggeration of the quality of the Product.

(2) Every container in which solvent-extracted oil or de-oiled meal or edible flour is packed for sale shall, at thetime of sale by the producer, bear the following particulars in English or Hindi (Devnagri script) :—

(i) the name, trade name, if any, or description of the solvent-extracted oil or de-oiled meal or edible flour,as the case may be:

(ii) in the case of oil not conforming to the standards of quality for “refined” grade solvent extracted oilsspecified in Regulation 5.2.7 (1) for Edible vegetable oil/Vanaspati, a declaration in a type-size of not less than50 mm, as follows shall appear on the label:

(a) “NOT FOR DIRECT EDIBLE CONSUMPTION”, in the case of oils complying with therequirements for the “semi-refined” or “raw-grade 1” grades of oil specified in Regulation 5.2.7 (1)

(b) “FOR INDUSTRIAL NON-EDIBLE USES ONLY”, in the case of oils not complying with therequirements under item (a) above;

(iii) the name and business particulars of the producer;

(iv) the net weight of the contents in the container;

(v) the batch number, month and year of manufacture:

Provided that where solvent extracted oils are transported in bulk in rail tank-wagons orroad tankers, or where de-oiled meal or edible flour is transported in bulk either for storage in silosor transferred to ship for bulk shipment, it shall be sufficient if the aforesaid particulars arefurnished in the accompanying documents.

(3) Every container in which solvent is packed shall, at the time of sale by the manufacturer or dealer thereof,bear the Indian Standards Institution certification mark

(4) Every container in which vanaspati, margarine, bakery shortening, blended edible vegetable oils, mixed fatspread and refined vegetable oil is packed in addition to other labelling requirements provided in these regugulationsshall bear the following particulars in English or Hindi in Devnagri script:

(a) the name/description of the contents, “free from Argemone Oil”;

(b) the mass/volume of the contents;

(5) Every container of refined vegetable oil shall bear the following label, namely:—

Refined (name of the Oil) Oil

Provided that the container of imported edible oil shall also bear the word, “Imported”, as prefix.

(6) Every package containing an admixture of palmolein with groundnut oil shall carry the following label,namely

Page 71: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

480 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

BLEND OF PALMOLEIN AND GROUNDNUT OIL

Palmolein......per cent

Groundnut oil....per cent

(7) Every package containing an admixture of imported rape-seed oil with mustard oil, shall carry the followinglabel, namely :

BLEND OF IMPORTED RAPE-SEED OILAND MUSTARD OIL

Imported rape-seed oil.....per cent

Mustard oil.......per cent

(8) Every package of vanaspati made from more than 30 percent of Rice bran oil shall bear the following label,namely:—

This package of vanaspati is made from morethan 30 per cent Rice bran oil by weight

(9) Every package containing Fat Spread shall carry the following labels namely:—

Milk Fat Spread

Use before ..............

Date of packing ............

Per cent by weight…………

Total Milk Fat Content ......

Mixed Fat Spread

Use before ..............

Date of packing ............

Per cent by weight…………

Milk Fat Content...........

Percent by weight.......

Total Milk Fat Content ......

Vegetable Fat Spread

Use before ..............

Date of packing ............

Per cent by weight…………

Total Fat Content ......

(10) A package cotaining annatto colour in vegetable oils shall bear the following label namely :—

Annatto colour in oil (Name of oil/oils) used

(11) Every package containing an admixture of edible oils shall carry the following label, namely:—

This blended edible vegetable oil contains an admixture of :

(i) ...................% by Weight

(ii) ................% by Weight

(Name and nature of edible vegetable oils i.e. in raw or refined form)

Date of Packing..................

Page 72: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 481

There shall also be the following declaration in bold capital letters along with the name of product onfront/central panel,–

NOT TO BE SOLD LOOSE

Regulation 4.4.3: Labelling of permitted food coulours(1) No person shall sell a permitted synthetic food colours for use in or upon food unless its container carries

a label stating the following particulars:—(i) the words “Food Colours”;(ii) the chemical and the common or commercial name and colour index of the dye-stuff.

(2) No person shall sell a mixture of permitted synthetic food colours for use in or upon food unless itscontainer carries a label stating the following particulars:—

(i) the words “Food Colour Mixture”;(ii) the chemical and the common or commercial name and colour index of the dye stuff contained in the

mixture.(3) No person shall sell a preparation of permitted synthetic food colours for use in or upon food unless its

container carries a label stating the following particulars:—(i) the words “Food Colour Preparation”;(ii) the name of the various ingredients used in the preparation.

Regulation 4.4.4: Labelling of irradiated Food

Irradiated foods.- The label of a food, which has been treated with ionizing radiation, shall carry a writtenstatement indicating the treatment in close proximity to the name of the food.

In addition all packages of irradiated food shall bear the following declaration and logo, namely:—

PROCESSED BY IRRADIATION METHODDate of Irradiation ..................

Licence No of Irradiation Unit......................................

PURPOSE OF IRRADIATION.....................

Regulation 4.4.5: Other Product Specific Labelling Requirements

(1) Coffee-Chicory Mixture:- (i) Every package containing a mixture of coffee and chicory shall have affixedto it a label upon which shall be printed the following declaration:

Coffee blended with Chicory

This mixture containsCoffee…………………………… Per centChicory………………………….. Per cent

(ii) Every package containing Instant Coffee-Chicory mixture shall have affixed to it a label upon whichshall be printed the following declarations;

Instant Coffee-Chicory mixture made fromblends of coffee and chicory

Coffee…………………………… Per centChicory………………………….. Per cent

Page 73: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

482 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Condensed Milk or Dessicated (Dried) Milk:

Every package containing condensed milk or desiccated (dried) milk shall bear a label upon which isprinted such one of the following declarations as may be applicable or such other declaration substantially tothe like effect as may be allowed by the State Government

(i) In the case of condensed milk (unsweetened):

CONDENSED MILK UNSWEETENED

(Evaporated Milk) (This tin contains the equivalent) of (x)......... litres of toned milk

(ii) In the case of condensed milk (sweetened):

CONDENSED MILK SWEETENED

This tin contains the equivalent of (x)......... litres of toned milk with sugar added

(iii) In the case of condensed skimmed milk (unsweetened):

CONDENSED SKIMMED MILK UNSWEETENED (Evaporated Skimmed Milk)This tin contains the equivalent of (x)......... litres of skimmed milk

(iv) In the case of condensed skimmed milk (sweetened):

CONDENSED SKIMMED MILK SWEETENED

This tin contains the equivalent of (x).......litres of skimmed milk with sugar added”

(v) In the case of condensed milk (sweetened and flavoured):

This has been flavoured with.............

NOT TO BE USED FOR

INFANTS BELOW SIX MONTHS

(vi) In the case of condensed milk/condensed Skimmed milk (unsweetened) Sterilised by UltraHigh Temperature (UHT) treatment:

This has been sterilised by UHT Process

(vii) In the case of milk powder:

MILK POWDER

This tin contains the equivalent of

(x)..... litres of toned milk

(viii) In the case of milk powder which contains lecithin:

MILK POWDER IN THIS PACKAGE CONTAINS LECITHIN

(ix) In the case of partly skimmed milk powder :

PARTLY SKIMMED MILK POWDER

This tin contains the equivalent of

(x)......... litres of partly skimmed milk

having......... per cent milk fat

(x) In the case of skimmed milk powder:

SKIMMED MILK POWDER

This tin contains the equivalent of (x)......... litres of skimmed milk

Page 74: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 483

(3) The declaration shall in each case be completed by inserting at (x) the appropriate number in words and infigures, for example, “one and a half (1½)”, any fraction being expressed as eight quarters or a half, as the case maybe.

(4) There shall not be placed on any package containing condensed milk or desiccated (dried) milk anycomment on, explanation of, or reference to either the statement of equivalence, contained in the prescribed declarationor on the words “machine skimmed” “skimmed” or “unsuitable for babies” except instructions as to dilution asfollows:

“To make a fluid not below the composition of toned milk or skimmed milk (as the case may be) with thecontents of this package, add (here insert the number of parts) of water by volume to one part by volume ofthis condensed milk or desiccated (dried) milk”

Sweetened condensed milk and other similar products which are not suitable for infant feeding shall notcontain any instruction of modifying them for infant feeding.

(5) Wherever the word “milk appears on the label of a package of condensed skimmed milk or of desiccated(dried) skimmed milk as the description or part of the description of the contents, it shall be immediately preceded orfollowed by the word “machine skimmed” or “partly skimmed”, as the case may be.

(6) Fluid milk: - The caps of the milk bottles shall clearly indicate the nature of the milk contained in them. Theindication may be either in full or by abbreviation shown below :

(i) Buffalo milk may be denoted by the letter ‘B’.

(ii) Cow milk may be denoted by the letter ‘C’

(iii) Goat milk may be denoted by the letter ‘G’

(iv) Standardized milk may be denoted by the letter ‘S’

(v) Toned milk may be denoted by the letter ‘T’

(vi) Double toned milk may be denoted by the letter ‘DT’

(vii) Skimmed milk may be denoted by the letter ‘K’

(viii) Pasteurised milk may be denoted by the letter ‘P; followed by the class of milk. For examplePasteurised Buffalo milk shall bear the letters ‘PB ‘.

(ix) alternatively colours of the caps of the milk bottles shall be indicative of the nature of milk containedin them, the classification of colours being displayed at places where milk is sold\stored or exhibited for sale,provided that the same had been simultaneously intimated to the concerned Local (Health) Authority, Othermedia of information like Press may also be utilised

(7) Ice cream — Every dealer in ice-cream or mixed ice-cream who in the street or other place of public resort,sells or offers or exposes for sale, ice-cream or ice-candy, from a stall or from a cart, barrow or other vehicle or froma basket, phial, tray or other container used without a staff or a vehicle shall have his name and address along withthe name and address of the manufacturer, if any, legibly and conspicuously ‘displayed’ on the stall, vehicle orcontainer as the case may be.

(8) Hingra :- Every container containing Hingra shall bear a label upon which is printed a declaration in thefollowing form, namely :

“This container contains Hingra ( Imported from Iran\Afghanistan) and is certified to be conforming tothe standards laid down in the Food Safety and Standards regulations”

(9) Light Black Pepper:- Every package containing light black pepper shall bear the following label in additionto the Agmark seal and the requirements prescribed under Regulation 4.2.1 and 4.2.2 of these Regulations:

Light Black Pepper (Light berries)

(10) Every package containing “Cassia Bark” shall bear the following

CASSIA BARK (TAJ)

Page 75: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

484 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(11) Every package containing “CINNAMON” shall bear the following label

CINNAMON (DALCHINI)

(12) Every package of chillies which contains added edible oil shall bear the following label:

CHILLIES IN THIS PACKAGE CONTAINS AN ADMIXTURE OF NOT MORE THAN 2 PERCENTOF……………….(NAME OF OIL) EDIBLE OIL

(13) Every package of ice-cream, kulfi, kulfa and chocolate ice-cream containing starch shall have a declarationon a label as specified in Regulation 4.7.1(2)

(14) Masala: Every package of mixed masala fried in oil shall bear the following label:

MIXED MASALA (FRIED) THIS MASALA HAS BEEN FRIED IN(Name of the edible oil used)

(15) Compounded Asafoetida: Every container of compounded asafoetida shall indicate the approximatecomposition of edible starch or edible cereal flour used in the compound, on the label

(16) Every package containing maida treated with improver or bleaching agents shall carry the following label,namely :

WHEAT FLOUR TREATED WITH IMPROVER/BLEACHING AGENTS, TO BE USED BY BAKERIES ONLY

(17) Unless otherwise provided in these regulations, every package of malted milk food which contains addednatural colouring matter except caramel, shall bear the following label, namely:

MALTED MILK FOOD IN THIS PACKAGE CONTAINS PERMITTED NATURAL COLOURING MATTER

(18) Every advertisement for and/or a package of food containing added Monosodium Glutamate shall carrythe following declaration, namely :—

This package of.............. (name of the food) contains added............ MONOSODIUM GLUTAMATE

NOT RECOMMENDED FOR INFANTS BELOW -12 MONTHS

(19) Every container of refined salseed fat shall bear the following label, namely:

REFINED SALSEED FAT FOR USE IN BAKERY AND CONFECTIONERY ONLY

(20) Every container or package of table iodised salt or iron fortified common salt containing permittedanticaking agent shall bear the following label, namely:—

IODIZED SALT / IRON FORTIFIED COMMON SALT* CONTAINS PERMITTED ANTICAKING AGENT

* Strike out whichever is not applicable

(21) Every container or package of iron fortified common salt shall bear the following label, namely

IRON FORTIFIED COMMON SALT

(22) Every package of Dried Glucose Syrup containing sulphur dioxide exceeding 40 ppm shall bear thefollowing label namely

DRIED GLUCOSE SYRUP FOR USE IN SUGAR CONFECTIONERY ONLY

(23) A package containing tea with added flavour shall bear the following label, namely:

“FLAVOURED TEA” (common name of permitted flavour/percentage) Registration No….

(24) Every package of food which is permitted to contain artificial sweetener mentioned in table given inRegulation 6.1.2 (1) of these Regulations and an advertisement for such food shall carry the following label,namely:—

(i) This contains ................. (Name of the artificial sweeteners).

(ii) Not recommended for children.

(iii) (a) *Quantity of sugar added ...……...... gm/100 gm.

Page 76: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 485

(b) No sugar added in the product.

(iv) *Not for Phenylketonurics (if Aspertame is added)

*strike out whatever is not applicable

(25) In addition to the declaration under Regulation 4.4.5 (24 & 26) every package of food which is permittedto contain artificial sweetener mentioned in table in Regulation 6.1.2 (1)of these Regulations and an advertisementfor such food shall carry the following label, namely:—”

CONTAINS ARTIFICIAL SWEETENER AND FOR CALORIE CONSCIOUS

(26) The declaration under Regulation 4.4.5 (25) shall be provided along with name or trade name of productand shall be half of the size of the name/ trade name. The declaration may be given in two sentences, but in the samebox:

(27) Every package of Aspertame (Methyl ester), Acesulfame K, Sucralose and Saccharin Sodium marketed asTable Top Sweetener and every advertisement for such Table Top Sweetener shall carry the following label, namely:—

Contains........... (name of artificial sweetener)

Not recommended for children

Provided that the package of aspertame (Methyl ester), marketed as Table Top Sweetener and everyadvertisement for such Table Top Sweetener shall carry the following label, namely:

Not for Phenylketonurics

(28) Every package of food which is permitted to contain a mixture of Aspertame (Methyl Ester) and AcesulfamePotassium Sweeteners mentioned in the Table given in Regulation 6.1.2 (1), shall carry the following label, namely:—

This ………........…… (Name of food) contains ………........……..... contains an admixture of Aspertame(Methyl Ester and Acesulfame Potassium. Not recommended for children.

(a) *Quantity of sugar added..…………... gm/100gm,

(b) No sugar added in the product.

*Not for Phenylketoneurics (if Aspertame is added)

*strike out whatever is not applicable

(29) Every package of food which is permitted to contain a mixture of Acesulfame Potassium and Sucralosesweeteners mentioned in the Table given in Regulation 6.1.2 (1), shall carry the following label, namely:—

(i) This …………(Name of Food) contains a mixture of Sucralose and Acesulfame Potassium;

(ii) Not recommended for children;

(iii) *(a) Quantity of sugar added………………………gm/100gm;

*(b) No sugar added in the product;

(*Strike out whichever is not applicable)

(30) Every package of Pan Masala and advertisement relating thereto, shall carry the following warning,namely:—

Chewing of Pan Masala is injurious to health

(31) Every package of supari and advertisement relating thereto shall carry the following warning in conspicuousand bold print, namely :—

Chewing of Supari is injurious to health

(32) Every package of fruit squash by whatever name it is sold, containing additional sodium or potassium saltshall bear the following label, namely :—

IT CONTAINS ADDITIONAL

Page 77: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

486 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

SODIUM/POTASSIUM SALT

(33) Every package of Cheese (hard., surface treated with Natamycin, shall bear the following label, namely :—

SURFACE TREATED WITH NATAMYCIN

(34) Every package of Bakery and Industrial Margarine made from more than 30 per cent of Rice Bran Oil shallbear the following label, namely :—

This package of Bakery & Industrial Margarine is made from more than 30 per cent of Rice Bran Oil by Wt

(35) Every container or package of flavour emulsion and flavour paste meant for use in carbonated or non-carbonated beverages shall carry the following declaration, in addition to the instructions for dilution, namely:—

FLAVOUR EMULSION AND FLAVOUR PASTE FOR USE IN CARBONATED OR NON-CARBONATEDBEVERAGES ONLY

(36) Every package of drinking water shall carry the following declaration in Capital letters having the size ofeach letter as prescribed in Regulation 4.3.3;

PACKAGED DRINKING WATER

One time usable plastic bottles of packaged drinking water shall carry the following declaration.

CRUSH THE BOTTLE AFTER USE

(37) Every package of mineral water shall carry the following declaration in capital letters having the size ofeach letter as prescribed in Regulation 4.3.3 ;

NATURAL MINERAL WATER

One time usable plastic bottles of mineral water shall carry the following declaration.

CRUSH THE BOTTLE AFTER USE

(38) Every package of food having added caffeine shall carry the following label, namely:—

CONTAINS CAFFEINE

Provided if caffeine is added in the products, it shall be declared on the body of the Container/bottle.

Provided also that in case of returnable glass bottles, which are recycled for refilling the Declaration ofcaffeine, may be given on the crown.

(39) Every package of Low Fat Paneer/ Chhana shall carry the following label, namely:—

LOW FAT PANEER / CHHANA

(40) Every package of Cheese(s., if packed in polyfilm/wrapping of cloth, shall bear the following label,namely:—

REMOVE THE OUTER PACKING BEFORE CONSUMPTION

(41) Every package of Frozen Desert / Frozen Confection shall bear the following label, namely:—

Frozen Desserts / Frozen Confection Contain ………………. Milk Fat / Edible Vegetable Oil* /and Vegetable Fat*

*strike out whatever is not applicable

(42) Every container or package of common salt shall bear the following label, namely:—

COMMON SALT FOR IODISATION* / IRON FORTIFICATION* /ANIMAL USE* / PRSERVATION /MEDICINE* / INDUSTRIAL USE*

*strike out whichever is not applicable.

(43) Every package of biscuits, bread and cakes containing Oligofructose shall bear the following declaration,namely:–

Contains Oligofructose (dietary fiber) —— gm/100 gm

Page 78: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 487

(44) Every package of fresh fruit if coated with wax shall carry the following label, namely

Coated with wax (give name of wax)

(45) Gelatin meant for human consumption should be labeled as “Gelatin Food Grade”

(46) Every package of food containing Polyols shall bear the following label

Polyols may have laxative effects

(47) Every package of food containing Polydextrose shall bear the following label

Polydextrose may have laxative effects

Regulation 4.4.6: Specific restrictions on Product labels

(1) Labels not to contain reference to Act or rules or regulations contradictory to required particulars – Thelabel shall not contain any reference to the Act or any of these regulations or any comment on, or reference to, orexplanation of any particulars or declaration required by the Act or any of these regulations to be included in thelabel which directly or by implication, contradicts, qualifies or modifies such particulars or declaration.

(2) Labels not to use words implying recommendations by medical profession – There shall not appear in thelabel of any package, containing food for sale the words “recommended by the medical profession” or any wordswhich imply or suggest that the food is recommended, prescribed, or approved by medical practitioners or approvedfor medical purpose.

(3) Unauthorized use of words showing imitation prohibited

(a) There shall not be written in the statement or label attached to any package containing any article offood the word “imitation” or any word or words implying that the article is a substitute for any food, unless theuse of the said word or words is specifically permitted under these regulations.

(b) Any fruit syrup, fruit juice, fruit squash, fruit beverages, cordial, crush or any other fruit productsstandardised under Chapter 5 of FSS Regulations, 2010 which does not contain the prescribed amount offruit juice or fruit pulp or fruit content shall not be described as a fruit syrup, fruit juice, fruit squash, fruitbeverages, cordial, crush or any other fruit product as the case may be.

(c) Any food product which does not contain the specified amount of fruit and is likely to deceive ormislead or give a false impression to the consumer that the product contains fruit, whether by use of words orpictorial representation, shall be clearly and conspicuously marked on the label as “(NAME OF THE FRUIT)FLAVOURED”.

(d) Any food product which contains only fruit flavours, whether natural flavours and natural flavouringsubstances or nature identical flavouring substances, artificial flavouring substances as single or in combinationthereof, shall not be described as a fruit product and the word “ADDED” (NAME OF FRUIT) FLAVOUR shallbe used in describing such a product;

(e) Carbonated water containing no fruit juice or fruit pulp shall not have a label which may lead theconsumer into believing that it is a fruit product.

(f) Any fruit and vegetable product alleged to be fortified with vitamin C shall contain not less than 40mgms. of ascorbic acid per 100 gm. of the product.

(4) Imitations not to be marked “pure”

The word “pure” or any word or words of the same significance shall not be included in the label of apackage that contains an imitation of any food.

(5) Labelling prohibitions for Drinking Water (Both Packaged and Mineral Water)

(i) No claims concerning medicinal (preventative, alleviative or curative) effects shall be made in respectof the properties of the product covered by the standard Claims of other beneficial effects related to the healthof the consumer shall not be made.

(ii) The name of the locality, hamlet or specified place may not form part of the trade name unless it refersto a packaged water collected at the place designated by that trade name.

Page 79: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

488 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(iii) The use of any statement or of any pictorial device which may create confusion in the mind of thepublic or in any way mislead the public about the nature, origin, composition, and properties of such watersput on sale is prohibited.

Note: Without prejudice to the standards laid down in this chapter, whenever water is used in the manufactureor preparation of any article of food, such water shall be free from micro-organisms likely to causedisease and also free from chemical constitutents which may impair health

Part 4.5: Restriction on advertisement

There shall be no advertisement of any food which is misleading or contravening the provisions of Food Safety andStandards Act, 2006 (34 of 2006) or the rules/regulations made thereunder.

Part 4.6: Exemptions from labelling requirements—

Regulations 4.6.1

(1) Where the surface area of the package is not more than 100 square centimeters, the label of such packageshall be exempted from the requirements of list of ingredients, Lot Number or Batch Number or Code Number,nutritional information and instructions for use, but these information shall be given on the wholesale packages ormulti piece packages, as the case may be.

(2) the ‘date of manufacture’ or ‘best before date’ or ‘expiry date’ may not be required to be mentioned on thepackage having surface area of less than 30 square centimeters but these information shall be given on the wholesalepackages or multipiece packages, as the case may be;

(3) in case of liquid products marketed in bottles, if such bottle is intended to be reused for refilling, therequirement of list of ingredients shall be exempted, but the nutritional information specified in Regulation 4.2.2 (4)these Regulations shall be given on the label.

PROVIDED that in case of such glass bottles manufactured after March 19, 2009, the list of ingredients andnutritional information shall be given on the bottle.

(4) in case of food with shelf-life of not more than seven days, the ‘date of manufacture’ may not be requiredto be mentioned on the label of packaged food articles, but the ‘use by date’ shall be mentioned on the label by themanufacturer or packer.

(5) In case of wholesale packages the particulars regarding list of ingredients. Date of manufacture andpacking, best before, labeling of irradiated food and logo, may not be specified.

Part 4.7: Notice of addition, admixture or deficiency in food

Regulations 4.7.1

(1) Every advertisement and every price or trade list or label for an article of food which contains an addition,admixture or deficiency shall describe the food as containing such addition, admixture or deficiency and shall alsospecify the nature and quantity of such addition, admixture or deficiency. No such advertisement or price or tradelist or label attached to the container of the food shall contain any words which might imply that the food is pure:

Provided that for purpose of this regulation the following shall not be deemed as an admixture or anaddition, namely:

(a) salt in butter or margarine,

(b) vitamins in food.

(2) Every package, containing a food which is not pure by reason of any addition, admixture or deficiency,shall be labelled with an adhesive label, which shall have the following declaration:

Declaration

This (a) ………. contains an admixture/addition of not more than (b) …… per cent. of (c).............

(a) Here insert the name of food.

(b) Here insert the quantity of admixture which may be present.

Page 80: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 489

(c) Here insert the name of the admixture or the name of ingredient which is deficient.

Where the context demands it, the words “contains an admixture of” shall be replaced by the words“contains an addition of” or “is deficient in”.

(3) Unless the vendor of a food containing an addition, admixture or deficiency, has reason to believe that thepurchaser is able to read and understand the declaratory label, he shall give the purchaser, if asked, the informationcontained in the declaratory label by word of mouth at the time of sale.

(4) Nothing contained in Regulation 4.7.1 shall be deemed to authorize any person to sell any article of foodrequired under the Act or these regulations to be sold in pure condition, otherwise than in its pure condition.

(5) Nothing contained in Regulation 4.7.1 shall apply in the case of sweets, confectionery, biscuits, bakeryproducst, processed fruits, aerated water, vegetables and flavouring agents.

CHAPTER 5FOOD PRODUCT STANDARDS

PART 5.1: Dairy Products and Analogues

Regulation 5.1.1: Milk

(1) Definitions:

1.1 Milk is the normal mammary secretion derived from complete milking of healthy milch animalwithout either addition thereto or extraction therefrom. It shall be free from colostrum. Milk of different classesand of different designations shall conform to the standards laid down in the Table below in Article 2.

Total urea content in the milk shall not be more than 700 ppm

1.2. Pasteurisation—

The terms “Pasteurisation”, “Pasteurised” and similar terms shall be taken to refer to the process ofheating every particle of milk of different classes to at least 630 C and holding at such temperature continuouslyfor at least 30 minutes or heating it to at least 71.50C and holding at such temperature continuously for at least15 seconds or an approved temperature time combination that will serve to give a negative Phosphatase Test.

All pasteurised milk of different classes shall be cooled immediately to a temperature of 100 C, or less

1.3. Sterilisation :The term “sterilisation when used in association with milk, means heating milk insealed container continuously to a temperature of either 1150 C for 15 minutes or at least 1300 C for a period ofone second or more in a continuous flow and then packed under aseptic condition in hermatically sealedcontainers to ensure preservation at room temperature for a period not less than 15 days from the date ofmanufacture;

1.4. Boiled Milk means milk which has been brought to boil.

1.5. Flavoured Milk, by whatever name called, may contain nuts (whole, fragmented or ground) chocolate,coffee or any other edible flavour, edible food colours and cane sugar. Flavoured milk shall be pasteurised,sterilised or boiled. The type of milk shall be mentioned on the label.

1.6. Mixed Milk means a combination of milk of cow, buffalo, sheep, goat or any other milch animal andmay be a combination of any of these milk which has been made and conforms to the standards given in theArticle 2 below.

1.7. Standardised Milk means cow milk or buffalo milk or sheep milk or goat milk or a combination of anyof these milk that has been standardised to fat and solids-not-fat percentage given in Article 2 below by theadjustment of milk solids. Standardised milk shall be pasteurised and shall show a negative Phosphatase Test.

1.8. Recombined Milk means the homogenised product prepared from milk fat, non-fat-milk solids andwater. Recombined milk shall be pasteurised and shall show a negative Phosphatase test.

1.9. Toned Milk means the product prepared by admixture of cow or buffalo milk or both with freshskimmed milk; or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not-fat percentage given in Article 2 below by adjustment of milk solids. It shall be pasteurised and shall show a

Page 81: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

490 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

negative Phosphatase Test. When fat or dry non-fat-milk solids are used, it shall be ensured that the productremains homogeneous and no deposition of solids takes place on standing.

1.10. Double Toned Milk means the product prepared by admixture of cow or buffalo milk or both withfresh skimmed milk, or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not-fat percentage given in Article 2 below by adjustment of milk solids. It shall be pasteurised and shallshow a negative Phosphatase Test. When fat or dry non-fat milk solids are used, it shall be ensured that theproduct remains homogeneous and no deposition of solids takes place on standing.

1.11. Skimmed Milk means the product prepared from milk from which almost all the milk fat has beenremoved mechanically.

1.12. Full Cream Milk means milk or a combination of buffalo or cow milk or a product prepared bycombination of both that has been standardised to fat and solids-not-fat percentage, given in Article 2 below,by adjustment/addition of milk solids, Full Cream Milk shall be pasteurised. It shall show a negative phosphatasetest. It shall be packed in clean, sound and sanitary containers properly sealed so as to prevent contamination.

1.13 Milk Products means the products obtained from milk such as cream, malai, curd, skimmed milkcurd, chhanna, skimmed-milk chhanna, cheese, processed cheese, ice-cream, milk ices, condensed milk-sweetened and unsweetened, condensed skimmed milk-sweetened and unsweetened, milk powder, skimmedmilk powder, partly skimmed milk powder, khoa, infant milk food, table butter and desi butter.

Milk products shall not contain any substance not found in milk unless specified in the standards.

(2) The standards of different classes and designations of milk shall be as given in the table below. Milk shallconform to both the parameters for milk fat and milk solids not fat, independently, as prescribed in columns (4) and(5) of the said table:

Minimum percentClass of Milk Designation Locality Milk Fat Milk solids not fat

(1) (2) (3) (4) (5)

Buffalo Milk Raw, pasteurized, Assam, 6.0 9.0boiled, flavoured, Bihar,sterlized Chandigarh

DelhiGujaratHaryanaJharkhandMaharashtraMeghalayaPunjabSikkimUttar PradeshUttarakhandWest BengalAndaman and NicobarAndhra PradeshArunachal PradeshChhatisgarhDadra & Nagar haveliGoa, Daman & DiuHimachal PradeshJammu & Kashmir & Karnataka

Page 82: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 491

Buffalo Milk Raw, pasteurized, Kerala 5.0 9.0boiled, flavoured, sterlized Lakshadweep, Minicoy & Amindivi Island

Madhya PradeshManipurMizoramNagalandOrissaPuducherryRajasthanTamil NaduTripura

Cow Milk Raw, pasteurized, boiled, Chandigarh 4.0 8.5flavoured, sterlized Haryana

PunjabCow Milk Raw, boiled, pasteurized, Andaman & Nicobar Islands 3.5 8.5

flavoured and sterlized Andhra PradeshArunachal PradeshAssamBiharChhatisgarhDadra & Nagar haveliDelhiGoa, Daman & DiuGujaratHimachal PradeshJammu & KashmirJharkhandKarnatakaKeralaLakshadweep, Minicoy & Adminidive IslandsMadhya PradeshMaharashtraManipurMeghalayaNagalandPuducherryRajasthanSikkimTamil NaduTripuraUttar PradeshUttarakhandWest Bengal

Cow Milk Raw, boiled, pasteurized, Mizoram 3.0 8.5flavoured and sterlized Orissa

Goat or Raw, boiled, pasteurized, Chandigarh 3.5 9.0

(1) (2) (3) (4) (5)

Page 83: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

492 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sheep Milk flavoured and sterlized ChhatisgarhHaryanaKeralaMadhya PradeshMaharashtraPunjabUttar PradeshUttarakhandAndaman & Nicobar IslandsAndhra PradeshArunachal PradeshAssamBiharChhatisgarhDadra and Nagar haveliDelhiGoa, Daman & DiuGujaratHimachal PradeshJammu & KashmirJharkhandKarnatakaLakshadweep, Minicoy & Amindive IslandsManipurMeghalaya’MizoramNagalandOrissaPuducherryRajasthanSikkim,Tamil NaduTripuraWest Bengal 3.0 9.0

Mixed Milk Raw, pasteurised, boiled, All India 4.5 8.5flavoured and sterilised

Standardized Pasteurised, flavoured All India 4.5 8.5milk and sterilizedRecombined Pasteurised, flavoured All India 3.0 8.5Milk and sterilizedToned Milk Pasteurised, flavoured All India 3.0 8.5

and sterilizedDouble Toned Pasteurised, flavoured All India 1.5 9.0milk and sterilizedSkimmed Milk Raw, boiled, pasteurised, All India Not more than 0.5 percent 8.7

flavoured and sterilizedFull Cream Milk Pasteurised and sterilized All India 6.0 9.0

(1) (2) (3) (4) (5)

Page 84: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 493

NOTE :- (i) When milk is offered for sale without indication of the class, the standards prescribed for buffalo milk shallapply.

(ii) The heat treatment for the various designated milk shall be as follows:

Designation Heat treatment

Raw Nil.Pasteurised Pasteurisation.Boiled BoilingFlavoured Pasteurisation or SterilisationSterilised Sterilisation

Regulation 5.1.2 CReam:

(1) Cream including sterilised cream means the product of cow or buffalo milk or a combination thereof. Itshall be free from starch and other ingredients foreign to milk. It may be of following three categories, namely:—

(1) Low fat cream—containing milk fat not less than 25.0 percent by weight.

(2) Medium fat cream—containing milk fat not less than 40.0 percent by weight.

(3) High fat cream—containing milk fat not less than 60.0 percent by weight.

Note:- Cream sold without any indication about milk fat content shall be treated as high fat cream.

(2) Cream Powder means the product obtained by partial removal of water from cream obtained from milk ofcow and/ or buffalo. The fat and / or protein content of the cream may be adjusted by addition and/ or withdrawal ofmilk constituents in such a way as not to alter the whey protein to casein ratio of the milk being adjusted. It shall beof uniform colour and shall have pleasant taste and flavour free from off flavour and rancidity. It shall also be freefrom vegetable oil/ fat, mineral oil, added flavour and any substance foreign to milk.

The product may contain food additives permitted in these Regulations and Appendices. It shall conform tothe microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 5.0 percent(ii) Milk fat Not less than 42.0 percent(iii) Milk protein in Milk solid not fat Not less than 34.0 percent

Regulation 5.1.3: Malai

(1) Malai means the product rich in butter fat prepared by boiling and cooling cow or buffalo milk or acombination thereof. It shall contain not less than 25.0 per cent milk fat.

Regulation 5.1.4: Dahi or Curd

(1) Dahi or Curd means the product obtained from pasteurised or boiled milk by souring, natural or otherwise,by a harmless lactic acid or other bacterial culture. Dahi may contain added cane sugar. Dahi shall have the sameminimum percentage of milk fat and milk solids-not-fat as the milk from which it is prepared.

Where dahi or curd is sold or offered for sale without any indication of class of milk, the standards prescribedfor dahi prepared from buffalo milk shall apply.

Milk solids may also be used in preparation of this product.

Regulation 5.1.5: Chhana or Paneer

(1) Chhana or Paneer means the product obtained from the cow or buffalo milk or a combination thereof byprecipitation with sour milk, lactic acid or citric acid. It shall not contain more than 70.0 per cent moisture and the milkfat content shall not be less than 50.0 per cent of the dry matter.

Milk solids may also be used in preparation of this product.

Page 85: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

494 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided that paneer or chhana when sold as low fat paneer or chhana, it shall conform to the followingrequirements:—

(i) Moisture Not more than 70.0 percent

(ii) Milk fat Not more than 15.0 percent of dry matter

Provided further that such low fat paneer/chhana shall be sold in sealed package only and shall bear properlabel declaration as provided in Regulation 4.4.5 (39).

Regulation 5.1.6: Cheese

“ Cheese1 (Hard) means the product obtained by draining after coagulation of milk with a harmless milkcoagulating agent under the influence of harmless bacterial culture. It shall not contain ingredients not found inmilk, except coagulating agent, sodium chloride, calcium chloride (anhydrous salt) not exceeding 0.02 percent byweight, annatto or carotene colour, and may contain emulsifiers and/or stabilizers, namely citric acid, sodium citrateor sodium salts of orthophosphoric acid and polyphosphoric acid (as linear phosphate) exceeding 0.2 percent byweight. Wax used for covering the outer surface shall not contain any thing harmful to health. In case the wax iscoloured, only permitted food colour shall be used. Hard cheese shall contain not more than 43.0 percent moistureand not less than 42.0 percent milk fat of the dry matter. Hard cheese may contain up to 3000 parts per million sorbicacid, or its sodium, potassium or calcium salts calculated as sorbic acid, and/or 12.5 parts per million nisin eithersingly or in combination.

Natamycin may be used for surface treatment only, subject to the following conditions, namely:—

(i) Maximum level of application shall not exceed 2 mg/dm3 of cheese surface

(ii) The penetration depth shall not exceed 2 mm.

(iii) The maximum residue level in the finished product shall not exceed 1 mg/dm3

Cheese2 means the ripened or unripened soft or semihard, hard and extra hard product, which may be coatedwith food grade waxes or polyfilm, and in which the whey protein / casein ratio does not exceed that of milk. Cheeseis obtained by coagulating wholly or partly milk and/ or products obtained from milk through the action of non-animal rennet or other suitable coagulating agents and by partially draining the whey resulting from such coagulationand/ or processing techniques involving coagulation of milk and/ or products obtained from milk which give a finalproduct with similar physical, chemical and organoleptic characteristics. The product may contain starter culturesof harmless lactic acid and / or flavour producing bacteria and cultures of other harmless microorganisms, safe andsuitable enzymes and sodium chloride. It may be in the form of blocks, slices, cut, shredded or grated cheese.

(i) Ripened Cheese is cheese which is not ready for consumption shortly after manufacture but whichmust be held for some time at such temperature and under such other conditions as will result in necessarybiochemical and physical changes characterizing the cheese in question.

(ii) Mould Ripened cheese is a ripened cheese in which the ripening has been accomplished primarily bythe development of characteristic mould growth through the interior and/ or on the surface of the cheese.

(iii) Unripened cheese including fresh cheese is cheese which is ready for consumption shortly aftermanufacture.

Cheese or varieties of cheeses shall have pleasant taste and flavour free from off flavour and rancidity.

It may contain food additives permitted in Appendix A. It shall conform to the microbiological requirementsprescribed in Appendix B:

1This standard for “Cheese (Hard)” is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pending finalapproval and are currently deferred till 31st Jan, 2011

2This is the revised standard for Cheese vide GSR 356 (E) dated 7th June, 2005, pending final approval and are currently deferred till 31st

January, 2011

Page 86: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 495

Provided that cheese or varieties of cheeses coated with food grade waxes/ or polyfilm / or wrapping of clothshall bear proper label declaration as provided in Regulation 4.4.5 (44) It shall conform to the following requirements:—

Product Moisture Milk Fat on Dry basis

(i) Hard Pressed Cheese Not more than 39.0 percent Not less than 48.0(ii) Semi Hard Cheese Not more than 45.0 percent Not less than 40.0 percent(iii) Semi Soft Cheese Not more than 52.0 percent Not less than 45.0 percent(iv) Soft Cheese Not more than 80.0 percent Not less than 20.0 percent(v) Extra Hard Cheese Not more than 36.0 percent Not less than 32.0 percent(vi) Mozzarella Cheese Not more than 60.0 percent Not less than 35.0 percent(vii) Pizza Cheese Not more than 54.0 percent Not less than 35.0 percent

(2) “ Processed Cheese”1 means the product obtained by heating one or mote types of hard cheeses withpermitted emulsifiers and/or stabilizers namely citric acid, sodium citrate, sodium salts of orthophoric acid andpolyphosphoric acid (as linear phosphate) with or without added condiments, and acidifying agents, namelyvinegar, lactic acid, acetic acid, citiric acid and phosphoric acid. Processed cheese may contain not more than 4.0percent of anhydrous permitted emulsifiers and/or stabilizers, provided that the content of anhydrous inorganicagents shall in no case exceed 3.0 percent of the finished product. It shall not contain more than 47.0 percentmoisture. Processed cheese chiplets (packed sliced cheese) when sold in a package other than tin, shall not containmore than 50.0 percent moisture. The milk fat content shall not be less than 40.0 percent of the dry matter. Processedcheese may contain upto 3000 parts per million sorbic acid , or its sodium, potassium or calcium salts calculated assorbic acid, and/or 12.5 parts per million nisin either singly or in combination. It may contain calcium chloride(anhydrous) not exceeding 0.02 percent by weight.

Processed Cheese2 means the product obtained by grinding, mixing, melting and emulsifying one or morevarieties of cheeses with the aid of heat and emulsifying agents. It may contain cream, butter, butter oil and othermilk products subject to maximum 5.0 percent lactose content in the final product and edible common salt, vinegar/ acetic acid, spices and other vegetable seasoning and foods other than sugars properly cooked or prepared forflavouring and characterization of the product provided these additions do not exceed one sixth of the weight of thetotal solids of the final product on dry matter basis and cultures of harmless bacteria and enzymes. It shall havepleasant taste and smell free from off flavour and rancidity. It may contain food additives permitted in Appendix A.It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

(i) Moisture - Not more than 47.0 percent

(ii) Milk fat on dry basis - Not less than 40.0 percent.

PROVIDED that processed cheese chiplets (packed sliced cheese) when sold in a package other than tin, shallnot contain more than 50.0 percent moisture.

(3) “ Processed Cheese Spread3 means a product obtained by comminuting and mixing one or more types ofcheese into a homogenous mass with the aid of heat. It may or may not contain butter, cream, butter oil, milk,skimmed milk, milk powder, cheese whey, sweet butter milk or one or more of these or any of these from which partof water has been removed. It may also contain permitted emulsifying and stabilizing agents. It may also contain oneor more of the sodium/potassium salts of citric acid, phosphoric acid, tartaric acid, lactic acid in such quantities thatmass of the solids of such emulsifying agents is not more than 4 percent of mass of the processed cheese spread.It may contain sequestering and buffering agents, namely, lactic acid, acetic acid, citric acid and phosphoric acid.

It may contain vegetable colouring matter such as annatto, carotene, permitted flavouring agents and milkcoagulating enzymes with or without purified Calcium Chloride (anhydrous salt) not exceeding 0.02 percent and

1 This standard for “Processed Cheese” is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pending finalapproval and are currently deferred till 31st January, 2011

2 This is the revised standard for Processed Cheese vide GSR 356 (E) dated 7th June, 2005, pending final approval and are currentlydeferred till 31st January, 2011

3 This standard for Processed Cheese Spread is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pendingfinal approval and are currently deferred till 31st January, 2011

Page 87: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

496 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

sodium citrate not exceeding 2.0 percent. it may contain natural sweetening agents, namely, sugar, dextrose canesugar, corn syrup, honey, corn syrup soild, maltose, malt syrup and hydrolyzed lactose in a quantity necessary forseasoning and spices and condiments. It may contain sodium Chloride not exceeding 3 percent by weitght. Processedcheese spread may contain up to 3000 parts per million sorbic acid or its sodium, potassium salts calculated assorbic acid and or 12.5 parts per million nisin. It shall not contain more than 60 percent moisture and milk fat content(on dry basis) shall not be less than 40 percent by weight.

Processed Cheese Spread1 means the product obtained by grinding, mixing, melting and emulsifying one ormore varieties of cheese with emulsifying agents with the aid of heat. It may contain Cream, Butter oil and other dairyproducts, subject to a maximum limit of 5.0 percent lactose in the final product, salt, vinegar, spices, condiments andseasonings, natural carbohydrate sweetening agents namely sucrose, dextrose, corn syrup, corn syrup solids,honey, maltose, malt syrup and hydrolysed lactose and food properly cooked or otherwise prepared for flavouringand characterization of the product provided these additions do not exceed one sixth of the weight of total solids ofthe final product on dry weight basis and cultures of harmless bacteria and enzymes. It shall have pleasant taste andflavour free from off flavour and rancidity. It may contain food additives permitted in Appendix A. It shall conform tothe microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture - Not more than 60.0 percent

(ii) Milk fat on dry basis - Not less than 40.0 percent.

(4) Cheddar Cheese means ripened hard cheese obtained by coagulating heated/pasteurised milk of Cow and/or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or othersuitable coagulating enzymes. It shall be in the form of hard pressed block with a coating of food grade waxes orwrapping of cloth or polyfilm. It shall have firm, smooth and waxy texture with a pale straw to orange colour withoutany gas holes. It may contain food additives permitted in these Regulations and Appendices including Appendix A.It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

(i) Moisture - Not more than 39.0 percent

(ii) Milk Fat on Dry Basis - Not less than 48.0 percent

(5) Danbo Cheese means ripened semi hard cheese obtained by coagulating heated /pasteurised milk of cowand/ or Buffalo and mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet orother suitable coagulating enzymes. It shall be smooth in appearance with firm texture and uniform yellow colourand may be coated with food grade waxes or wrapping of cloth or polyfilm. It may contain food additives permittedin these Regulations and Appendices. It shall conform to the microbiological requirements prescribed in. AppendixB. It shall conform to the following requirements:—

(i) Moisture Not more than 39.0 percent.

(ii) Milk Fat on Dry Basis Not less than 45.0 percent

(6) Edam Cheese means the ripened semi hard cheese obtained by coagulating heated / pasteurised milk ofCow and / or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria non-animal rennetor other suitable coagulating enzymes. It shall have a firm texture suitable for cutting with a yellowish colour and ahard rind which may be coated with food grade waxes, wrapping of cloth, polyfilm or vegetable oil. It may containfood additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirementsprescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture - Not more than 46.0 percent.

(ii) Milk Fat on Dry basis - Not less than 40.0 percent.

(7) Gouda Cheese means ripened semi hard cheese obtained by coagulating milk of Cow and/ or Buffalo ormixtures thereof with cultures of harmless lactic acid producing bacteria non-animal / rennet or other suitablecoagulating enzymes. It shall have firm texture suitable for cutting, straw to yellowish colour and a hard rind whichmay be coated with food grade waxes, wrapping of cloth, or vegetable oil. It may contain food additives permitted

1 This is the revised standard for Processed Cheese Spread vide GSR 356 (E) dated 7th June, 2005, pending final approval and arecurrently deferred till 31st January, 2011

Page 88: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 497

in these Regulations and Appendices. It shall conform to the microbiological requirements prescribed in AppendixB. It shall conform to the following requirements:—

(i) Moisture Not more than 43.0 percent

(ii) Milk Fat on Dry Basis Not less than 48.0 percent.

(8) Havarti Cheese means ripened semi hard cheese obtained by coagulating milk of cow and / or Buffalo ormixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitablecoagulating enzymes. It shall have firm texture suitable for cutting, a light yellow colour and may have a semi softslightly greasy rind. It may contain food additives permitted in these Regulations and Appendices. It shall conformto the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements Havarti 30 percent Havarti 60 percent Havarti

Moisture Not more than 48.0 percent Not more than 53.0 percent Not more than 60.0 percent

Milk Fat on Dry basis Not less than 45.0 percent Not less than 30.0 percent Not less than 60.0 percent.Basis

(9) Tilsiter means ripened semi hard cheese obtained by coagulating milk of Cow and/ or Buffalo or mixturesthereof with cultures of harmless lactic acid producing bacteria and cultures of Bacterium linens, non-animal rennetor other suitable coagulating enzymes. It shall have firm texture suitable for cutting with a ivory to yellow colourwith a firm rind which may show red and yellow smear producing bacteria or coated with food grade waxes orwrapping of cloth or polyfilm after removal of the smear. It may contain food additives permitted in these Regulationsand Appendices. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform tothe following requirements:–

Requirement Tilsiter 30 percent Tilsiter 60 percent Tilsiter

Moisture Not more than 47.0 percent Not more than 53.0 percent Not more than 39.0 percent

Milk fat on Dry Basis Not less than 45.0 percent Not less than 30.0 percent Not less than 60.0 percent

(10) Cottage Cheese and Creamed Cottage Cheese means soft unripened cheese obtained by coagulation ofpasteurised skimmed milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid bacteriawith or without the addition of other suitable coagulating enzymes. Creamed Cottage Cheese is cottage cheese towhich a pasteurised creaming mixture of cream, skimmed milk, condensed milk, non fat dry milk, dry milk protein,Sodium/ Potassium/ Calcium/ Ammonium caseinate is added. It shall have a soft texture with a natural white colour.It may contain spices, condiments, seasonings and fruits pulp. It may contain food additives permitted in theseRegulations and Appendices. It shall conform to the microbiological requirements prescribed in Appendix B. It shallconform to the following requirements:—

(i) Moisture Not more than 80.0 percent

(ii) Milk Fat(in Creamed Cottage Cheese) Not less than 4.0 percent

(11) Cream Cheese (Rahmfrischkase) means soft unripened cheese obtained by coagulation of pasteurisedmilk of cow and / or buffalo or mixtures thereof and pasteurised cream with cultures of harmless lactic acid producingbacteria with or without the addition of suitable coagulating enzymes. It shall have a soft smooth texture with awhite to light cream colour. It may contain spices, condiments, seasonings and fruits pulp. The product may containfood additives permitted in these Regulations and Appendices. It shall conform to the microbiological requirementsprescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 55.0 percent.

(ii) Milk Fat on Dry Basis Not less than 70.0 percent.

(12) Coulommiers Cheese means soft unripened cheese obtained by coagulation of milk of cow and /orbuffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria and non-animal rennet or othersuitable coagulating enzymes and moulds characteristic of the variety. It shall have soft texture and white to creamyellow colour and may show presence of white mould including orange or red spots on the surface. It may contain

Page 89: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

498 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

food additives permitted in these Regulations and Appendices. It shall conform to the microbiological requirementsprescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 56.0 percent

(ii) Milk Fat on Dry Basis Not less than 46.0 percent

(13) Camembert Cheese means ripened soft cheese obtained by coagulating milk of Cow and/ or Buffalo ormixtures thereof with cultures of harmless lactic acid producing bacteria and cultures of Penicillium caseicolum andBacterium linens non-animal rennet or other suitable coagulating enzymes. It may be in the form of flat cylindricalshaped cheese covered with white mould (Penicillum caseicolum) with occasional orange coloured spots (Bacteriumlinens) It may contain food additives permitted in these Regulations and Appendices. It shall conform to themicrobiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements 30.0 percent 40.0 percent 45.0 percent 50.0 percentCamembert cheese Camembert cheese Camembert cheese Camembert cheese

Moisture Not more than Not more than Not more than Not more than62.0 percent 56.0 percent 56.0 percent 56.0 percent

Milk fat on Not less than Not less than Not less than Not less thanDry Basis 30.0 percent 40.0 percent 45.0 percent 50.0 percent

(14) Brie Cheese means soft ripened cheese obtained by coagulating milk of Cow and/ or Buffalo or mixturesthereof with cultures of harmless lactic acid producing bacteria and cultures of Penicillium caseicolum and Bacteriumlinens, non-animal rennet and other suitable enzymes. It shall be white to creamy yellow in colour with a smoothtexture showing presence of white mould (Penicillium caseicolum) with occasional orange coloured spots (Bacteriumlinens) on the rind. It may contain food additives permitted in Appendix A. It shall conform to the microbiologicalrequirements prescribed in Appendix B.

It shall conform to the following requirements:—

(i) Moisture Not more than 56.0 percent

(ii) Milk Fat on Dry basis Not less than 40.0 percent

(15) Saint Paulin - means ripened semi hard cheese obtained by coagulating milk of Cow and / or Buffalo ormixtures thereof with non-animal rennet, cultures of harmless lactic acid producing bacteria or other suitable enzymes.It shall have white to yellow colour with a firm and flexible texture and a hard rind which may be coated with foodgrade waxes or polyfilm. It may contain food additives permitted in these Regulations and Appendices. It shallconform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 56.0 percent

(ii) Milk Fat on Dry Basis Not less than 40.0 percent

(16) Samsoe means hard ripened cheese obtained by coagulating milk of Cow and /or Buffalo or combinationthere of with non-animal rennet and cultures of harmless lactic acid producing bacteria or suitable coagulatingenzymes. It shall be yellow in colour with a firm texture suitable for cutting and may have a rind with or without foodgrade waxes or polyfilm coating. It may contain food additives permitted in these Regulations and Appendices. Itshall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

Requirements Samsoe 30 percent Samsoe

(i) Moisture Not more than 44.0 percent Not more than 50.0 percent

(ii) Milk Fat on Dry Basis Not less than 45.0 percent Not less than 30.0 percent

(17) Emmentaler means hard ripened cheese with round holes obtained by coagulating milk of Cow and/ orBuffalo or mixtures thereof with non-animal rennet, cultures of harmless lactic acid producing bacteria or othersuitable coagulating enzymes. It may contain Cupric Sulphate not exceeding 15 mgm/Kg expressed as Copper. Itshall have a light Yellow colour and a firm texture suitable for cutting and may have a hard rind. It may contain food

Page 90: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 499

1 This standard for Ice Cream, Kulfi and Chocolate Ice Cream is currently in force, the revised standards vide GSR 356 (E) dated 7th

June, 2005 is pending final approval and are currently deferred till 6th September, 2010.2 This is the revised standard for Ice Cream, Kulfi, Chocolate Ice Cream or Softy Ice Cream vide GSR 356 (E) dated 7th June, 2005, pending

final approval and are currently deferred till 6th September, 2010.

additives permitted in these Regulations and Appendices. It shall conform to the microbiological requirementsprescribed in Appendix B.

It shall conform to the following requirements:—

(i) Moisture Not more than 40.0 percent.

(ii) Milk Fat on Dry Basis Not less than 45.0 percent

(18) Provolone means pasta filata cheese obtained by coagulating milk of Cow and/ or Buffalo or mixturesthereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitable coagulatingenzymes. It may be smoked. It shall be white to yellow straw in colour with a fibrous or smooth body and rind whichmay be covered with vegetable fat/ oil, food grade waxes or polyfilm. It may contain food additives permitted inthese Regulations and Appendices. It shall conform to the microbiological requirements prescribed in Appendix B.It shall conform to the following requirements:—

(i) Moisture —

(a) Unsmoked Cheese Not more than 47.0 percent

(b) Smoked Cheese Not more than 45.0 percent

(ii) Milk Fat on Dry Basis Not less than 45.0 percent

(19) Extra Hard Grating Cheese means ripened cheese obtained by coagulating milk of Cow and/ or Buffalo,goat/ sheep milk or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet, orother suitable coagulating enzymes. It may be white to light cream in colour with a slightly brittle texture and an extrahard rind which may be coated with vegetable oil, food grade waxes or polyfilm. It may contain food additivespermitted in these Regulations and Appendices. It shall conform to the microbiological requirements prescribed inAppendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 36.0 percent

(ii) Milk Fat on Dry Basis Not less than 32.0 percent

Regulation 5.1.7: Dairy Based Desserts/ Confections

(1) “ Ice Cream, Kulfi and Chocolate1 Ice Cream means frozen product obtained from cow or buffalo milk ora combination thereof or from cream and/or other milk products, with or without the addition of cane sugar, dextrose,liquid glucose and dried liquid glucose, Maltodextrin, eggs, fruits, fruit juices, preserved fruits, nuts, chocolate,edible flavours and permitted food colours. It may contain permitted stabilizers and emulsifiers not exceeding 0.5percetn by weight. The mixture shall be suitably heated before freezing. The product shall contain not less than 10.0percent milk fat, 3.5 percent protein and 36.0 percent total solids. Starch may be added to a maximum extent of 5.0percent under a declaration on a label as specified in Regulation 4.7.1(2)

The standards for ice cream shall also apply to softy ice-cream.

In case of ice-cream, where the chocolate or like covering portion forms a separate layer, only the ice-creamportion shall conform to the standards of ice-cream.

Ice Cream, Kulfi, Chocolate Ice Cream or Softy Ice Cream2 means the product obtained by freezing apasteurised mix prepared from milk and/ or other products derived from milk with the addition of nutritive sweeteningagents e.g. Sugar, Dextrose, Fructose, Liquid Glucose, Dried liquid glucose, maltodextrin, high maltose corn syrup,honey, fruit and fruit products, eggs and egg products, coffee, cocoa, ginger and nuts. It may also contain Chocolate,and bakery products such as Cake, or Cookies as a separate layer and / or coating. It may be frozen hard or frozento a soft consistency. It shall be free from artificial sweetener. It shall have pleasant taste and smell free from offflavour and rancidity. It may contain food additives permitted in Appendix A. It shall conform to the microbiologicalrequirements prescribed in Appendix B. It shall conform to the following requirements:—

Page 91: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

500 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Requirement Ice Cream Medium Fat Ice Cream Low Fat Ice Cream

Total Solid Not less than 36.0 percent Not less than 30.0 percent Not less than 26.0 percent

Wt/Vol (gms/1) Not less than 525 Not less than 475 Not less than 475

Milk Fat Not less than 10.0 percent Not less than 5.0 percent but Not more than 2.5 percent less than 10.0 percent

Milk Protein Not less than 3.5 percent Not less than 3.5 percent Not less than 2.5 percent(Nx6.38)

Note: In case where Chocolate, Cake or similar food coating, base or layer forms a separate part of the product only theIce Cream portion shall conform to the requirements given above. The type of ice-cream shall be clearly indicatedon the label otherwise standard for ice-cream shall apply.

(2) Dried Ice Cream Mix1 shall be the material prepared by spray or other roller drying of ice-cream mix. It shallcontain milk solids, sucrose or corn syrup or refined sugar. It may contain permitted colours and flavours. It maycontain stabilizers and emulsifiers not exceeding 1.25 percent by weight. The product shall contain not less than27.0 percent milk fat and 9.5 percent protein and moisture shall not be more than 4 percent by weight. The sucrosecontent shall be not more than 40 percent by weight.

The process of drying shall be mentioned on the table. It shall be packed in hermatically sealed containers.

Dried Ice Cream Mix/ Dried Frozen Dessert/ Confection1 means the product in a powder form which onaddition of prescribed amount of water shall give a product conforming to the requirements of the respectiveproducts, namely - ice cream, medium fat ice-cream, low fat ice-cream as prescribed under Regulation 5.1.7 (1) andfrozen confection, medium fat frozen confection and low fat frozen confection as prescribed under Regulation 5.1.7(3) of these regulations except the requirement of weight /volume for both the products. The moisture content of theproduct shall not be more than 4.0 percent. It may contain food additives permitted in Appendix A. It shall conformto the microbiological requirements prescribed in Appendix B.

(3) Frozen Dessert / Frozen Confection3 means the product obtained by freezing a pasteurised mix preparedwith milk fat and / or edible vegetable oils and fat having a melting point of not more than 37.0 degree C incombination and milk protein alone or in combination / or vegetable protein products singly or in combination withthe addition of nutritive sweetening agents e.g. sugar, dextrose, fructose, liquid glucose, dried liquid glucose,maltodextrin, high maltose corn syrup, honey, fruit and fruit products, eggs and egg products coffee, cocoa, ginger,and nuts. It may also contain chocolate, cake or cookies as a separate layer or coating. It may be frozen hard orfrozen to a soft consistency. It shall be free from artificial sweetener. It shall have pleasant taste and flavour free fromoff flavour and rancidity. The product may contain food additives permitted in these Regulations and Appendices.It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

Requirement Frozen Dessert/ Medium Fat Frozen Dessert/ Low Fat Frozen Dessert/ Frozen Confection Frozen Confection Frozen Confection

Total Solid Not less than 36.0 percent Not less than 30.0 percent Not less than 26.0 percent

Wt/Vol (gms/1) Not less than 525 Not less than 475 Not less than 475

Total Fat Not less than 10.0 percent Not less than 5.0 percent but Not more than 2.5 percentless than 10.0 percent

Total Protein Not less than 3.5 percent Not less than 3.5 percent Not less than 2.5 percent(N x 6.25)

1 This is the revised standard for Dried Ice Cream Mix/Dried frozen dessert/confection vide GSR 356 (E) dated 7th June, 2005, pendingfinal approval and are currently deferred till 31st January, 2011.

2 This standard for Dried Ice Cream Mix is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pendingfinal approval and are currently deferred till 31st January, 2011.

3 The said standards for Frozen Dessert/ Frozen confection are deffered till 6th September and will be in force on or after 31st January,2011.

Page 92: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 501

Note:- In case where Chocolate, Cake or similar food coating, base or layer forms a separate part of the product only thefrozen dessert/ confection portion shall conform to the requirements given above. The type of frozen confectionshall be clearly indicated on the label otherwise, standards of frozen dessert / frozen confection shall apply andevery package of Frozen Dessert / Frozen Confection shall bear proper label declaration under Regulation 4.4.5(41).

(4) “Milk Ices or Milk Lollies1 means the frozen product obtained from milk, skimmed milk or milk productwith or without the addition of cane siugar, dextrose, liquid glucose, and dried glucose, eggs, fruits, nuts, chocolate,edible flavours and permitted food colours. It may contain permitted stabilizers not exceeding 0.5 percent of theproduct. The mixture shall be suitably heat-treated before freezing. The product shall contain not more than 2.0percent milk fat, not less than 3.5 percent proteins and not less than 20.0 percent total solids.

Milk Ice or Milk Lolly2 means the product obtained by freezing a pasteurised mix prepared from milk and / orother products derived from milk with the addition of natural sweetening agents i.e. Sugar, Dextrose, Fructose,Liquid glucose, Dried liquid glucose, maltodextrin, honey, fruit and fruit products, eggs and egg products, coffee,cocoa, ginger, and nuts. It may also contain Chocolate, and bakery products such as Cake or Cookies as a separatelayer and /or coating. It shall be free from artificial sweetener. It shall have pleasant taste and smell free from offflavour and rancidity. It may contain food additives permitted in these Regulations and Appendices. It shall conformto the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:–

(1) Total solids (m/m) Not less than 20.0 percent

(2) Milk Fat (m/m) Not more than 2.0 percent

(3) Milk Protein (Nx6.38) Not less than 3.5 percent

(5) Khoya by whatever variety of names it is sold such as Pindi, Danedar, Dhap, Mawa or Kava means theproduct obtained from cow or buffalo or goat or sheep milk or milk solids or a combination thereof by rapid drying.The milk fat content shall not be less than 30 percent on dry weight basis of finished product. It may contain citricacid not more than 0.1 per cent by weight. It shall be free from added starch, added sugar and added colouringmatter.

Regulation 5.1.8: Evaporated/ Condensed Milk & Milk Products

(1) Evaporated Milk means the product obtained by partial removal of water from milk of cow and/ or buffaloby heat or any other process which leads to a product of the same composition and characteristics. The fat andprotein content of the milk may be adjusted by addition and/ or withdrawal of milk constituents in such a way as notto alter the whey protein to casein ratio of the milk being adjusted. It shall have pleasant taste and flavour free fromoff flavour and rancidity. It shall be free from any substance foreign to milk. It may contain food additives permittedin Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to thefollowing requirements:—

Product Milk Fat Milk Solids Milk Protein in milk solidsnot fat

(i) Evaporated milk Not less than 8.0 percent Not less than 26.0 percent Not less than 34.0 percentm/m m/m m/m

(ii) Evaporate partly Not less than 1.0 percent and Not less than 20.0 percent Not less than 34.0 percentskimmed milk not more than 8.0 percent m/m m/m m/m

(iii) Evaporated skimmed Not more than 1.0 percent m/m Not less than 20.0 percent Not less than 34.0 percentmilk m/m m/m

(iv) Evaporated high Not less than 15.0 percent m/m Not less than 11.5 percent Not less than 34.0 percentfat milk m/m m/m

1 This standard for Milk Ices or Milk Lollies is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pendingfinal approval and are currently deferred till 31st January, 2011

2 This is the revised standard for Milk Ice or Milk Lolly vide GSR 356 (E) dated 7th June, 2005, pending final approval and arecurrently deferred till 31st January, 2011

Page 93: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

502 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Sweetened Condensed Milk means the product obtained by partial removal of water from milk of Cow and/or Buffalo with the addition of sugar or a combination of sucrose with other sugars or by any other process whichleads to a product of the same composition and characteristics. The fat and/ or protein content of the milk may beadjusted by addition and / or withdrawal of milk constituents in such a way as not to alter the whey protein to caseinratio of the milk being adjusted. It shall have pleasant taste and flavour free from off flavour and rancidity. It shall befree from any substance foreign to milk. It may contain food additives permitted in these Regulations and Appendices.It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

Product Milk Fat Milk Solids Milk Protein in milk solidsnot fat

(i) Sweetened condensed Not less than 9.0 percent m/m Not less than 31.0 percent Not less than 34.0 percentmilk m/m m/m

(ii) Sweetened condensed Not more than 1.0 percent m/m Not less than 26.0 percent Not less than 34.0 percentskimmed milk m/m m/m

(iii) Sweetened condensed Not less than 3.0 percent m/m Not less than 28.0 percent Not less than 34.0 percentpartly skimmed milk and not more than 9.0 percent m/m m/m m/m

(iv) Sweetened condensed Not less than 16.0 percent m/m Not less than 30.0 percent Not less than 34.0 percenthigh fat milk m/m m/m

(3) Milk Powder - means the product obtained by partial removal of water from milk of Cow and / or Buffalo.The fat and / or protein content of the milk may be adjusted by addition and/ or withdrawal of milk constituents insuch a way as not to alter the whey protein to casein ratio of the milk being adjusted. It shall be of uniform colour andshall have pleasant taste and flavour free from off flavour and rancidity. It shall also be free from vegetable oil/ fat,mineral oil, thickening agents, added flavour and sweetening agent. It may contain food additives permitted in theseRegulations and Appendices. It shall conform to the microbiological requirements prescribed in Appendix B. It shallconform to the following requirements:—

Product Moisture Milk Fat Milk protein Titrable acidity Solubility Total ashin milk solids (ml 0.1N NAOH / Percent on dryand not fat 10 gm solids weight

not fat) basis

(i) Whole milk Not more than Not less than Not less than Not less than 18.0 Not less than 99 Not less thanpowder 4.0 percent m/m 26.0 percent m/m 34.0 percent m/m 7.3 percent

(ii) Partly Not more than Not less than Not less than Not less than 18.0 Not less than 99 Not less thanSkimmed 5.0 percent 1.5 percent m/m 34.0 percent m/m 8.2 percentmilk and not more thanPowder 26.0 percent m/m

(iii) Skimmed Not more than Not less than Not less than Not less than 18.0 Not less than 99 Not less thanmilk 5.0 percent 1.5 percent m/m 34.0 percent m/m 8.2 percentpowder

Regulation 5.1.9: Foods For Infant Nutrition

(1) Infant Milk Food means the product prepared by spray drying of the milk of cow or buffalo or a mixturethereof. The milk may be modified by the partial removal/substitution of different milk solids; carbohydrates, suchas sucrose, dextrose and dextrins/maltodextrin, maltose and lactose; salts like phosphates and citrates; vitamins A,D, E, B Group, Vitamin C and other vitamins; and minerals like iron, copper, zinc and iodine. The source of MineralSalts and Vitamin Compounds may be used from:—

(1) Calcium (Ca) - Calcium carbonate, Calcium chloride, Calcium citrate, Calcium phosphate monobasic,Calcium phosphate dibasic, Calcium phosphate tribasic;

Page 94: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 503

(2) Phosphorous (P) - Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphatetribasic, Magnesium phosphate dibasic, Potassium phosphate dibasic;

(3) Chloride (Cl) - Calcium chloride, Choline chloride, Magnesium chloride, Manganese chloride, Sodiumchloride, Sodium chloride iodized;

(4) Iron (Fe) - Ferrous citrate, Ferrous lactate, Ferrous sulphate, Ferric pyrophosphate;(5) Magnesium (Mg) - Magnesium chloride, Magnesium oxide, Magnesium phosphate dibasic;(6) Sodium (Na) - Sodium bicarbonate, Sodium chloride, Sodium chloride iodized, Sodium citrate, Sodium

phosphate monobasic;(7) Potassium (K) - Potassium phosphate dibasic;(8) Copper (Cu) - Cupric citrate, Cupric sulphate;(9) Iodine (I) - Potassium iodide, Sodium iodide;(10) Zinc (Zn) - Zinc sulphate;(11) Manganese (Mn) - Manganese chloride, Manganese sulphate;(12) Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;(13) Provitamin A - Beta-carotene;(14) Vitamin D - Vitamin D2 - Ergocalciferol, Vitamin D3 - Cholecalciferol, Cholecalciferol-cholesterol;(15) Vitamin E - d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl-alpha-

tocopheryl acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;(16) Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamine mononitrate;(17) Riboflavin (Vitamin B2) - Riboflavin, Riboflavin 5' -phosphate sodium;(18) Niacin - Nicotinamide, Nicotinic acid;(19) Vitamin B6 - Pyridoxine hydrochloride;(20) Biotin (Vitamin H) - d-biotin;(21) Folacin - Folic acid;(22) Pantothenic acid - Calcium pantothenate, Panthenol;(23) Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;(24) Vitamin K - Phytylmenaquinone;(25) Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;(26) Choline - Choline bitartrate, Choline chloride;(27) Inositol;(28) Selenium - Sodium selenite.

The product shall be free of lumps and shall be uniform in appearance. It shall be free from starch and addedantioxidants. It shall also be free from dirt, extraneous matter, preservatives and added colour and flavour and fromany material which is harmful to human health. It shall not have rancid taste or musty odour. It shall not contain foodadditives.

It shall conform to the following requirements, namely:—1. Moisture, per cent by weight (not more than) 4.52. Total milk protein, per cent by weight (not less than) 12.03. Milk fat, per cent by weight (not less than) 18.04. Total ash, per cent by weight (not more than) 8.55. Ash insoluble in dilute Hydrochloric acid, per cent by weight (not more than) 0.16. Solubility:

Solubility Index maximum 2.0 mlSolubility per cent by weight (not less than) 98.5

Page 95: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

504 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

7. Vitamin A (as retinol) ìg. per 100 g. (not less than) 350 ìg

8. Added Vitamin D (expressed as Cholecalciferol or Ergocalciferol) ìg per 100g.(not less than) 4.5 ìg

9. Vitamin C, mg per 100 g. (not less than) 35 mg

10. Thiamine, ìg per 100 g. (not less than) 185 ìg

11. Riboflavin, ìg per 100 g. (not less than) 275 ìg

12. Niacin, ìg per 100 g. (not less than) 1160 ìg

13. Pyridoxine ìg per 100 g. (not less than) 160 ìg

14. Folic acid, ìg per 100 g. (not less than) 20 ìg

15. Pantothenic acid, mg per 100 g. (not less than) 1.4 mg

16. Vitamin B12, μg per 100 g. (not less than) 0.7 μg

17. Choline, mg per 100 g. (not less than) 32 mg

18. Vitamin K μg per 100 g. (not less than) 18 μg

19. Biotin, μg per 100 g. (not less than) 7.0 μg

20. Sodium mg per 100 g. (not less than) 90 mg

21. Potassium, mg per 100 g. (not less than) 370 mg

22. Chloride, mg per 100 g. (not less than) 250 mg

23. Calcium, mg per 100 g. (not less than) 230 mg

24. Phosphorous, mg per 100 g. (not less than) 115 mg

25. Magnesium, mg per 100 g. (not less than) 22 mg

26. Iron, mg per 100 g. (not less than) 5.0 mg

27. Iodine, μg per 100 g. (not less than) 20 μg

28. Copper, μg per 100 g. (not less than) 280 μg29. Zinc, mg per 100 g. (not less than) and 2.5 mg

not more than 5.0 mg30. Manganese, μg per 100g. (not less than) 20 μg31. Selenium, μg per 100 g. (not less than) 14 μg32. Bacterial count, per g. (not more than) 10,00033. Coliform count absent in 0.1 gram34. Yeast and mould count absent in 0.1 gram35. Salmonella and Shigella absent in 25 gram36. E. coli absent in 0.1 gram37. Staphylococcus aureas absent in 0.1 gram

It shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from film orcombination or any of the substrate made of Board paper, polyethylene, polyester metallised film or in such a wayto protect from deterioration.

It may be packed in nitrogen or a mixture of nitrogen and carbon dioxide.

(2) Infant Formula means the product prepared by spray drying of the milk of cow or buffalo or mixturethereof. The milk may be modified by partial removal/substitution of milk fat with vegetable oils rich in polyunsaturatedfatty acids and/or by different milk solids; carbohydrates such as sucrose, dextrose and dextrins/ maltodextrin,maltose and lactose; salts such as phosphates and citrates; vitamins A, D, E, B and C group and other vitamins;minerals such as iron, copper, zinc and iodine and others. Vegetables oils rich in polyunsaturated fatty acids shall be

Page 96: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 505

added to partially substitute milk fat to an extent that the product shall contain a minimum of 12 per cent by weightof milk fat and a minimum of linoleate content of 1.398 g per 100 g. of the product.

The products shall also contain a minimum of 0.70 I.U. of vitamin E per 100 kcal. It may contain in addition tothe vitamins and minerals listed, other nutrients may be added when required in order to provide nutrients ordinarilyfound in human milk such as, —

1. Carotenes Not less than 0.25 mg/L2. Fluorine Not less than 0.107 mg/L3. Amino acids Not less than 9 mg/L (only L forms of amino acids should be used)4. Non-protein nitrogen Not less than 173 mg/L5. Nucleotides Not less than 11.7 mg/L6. Carnitine Not less than 11.27 μg/L7. Lactalbumin Not less than 1.4 g/L8. Lactoferrin Not less than 0.27 g/L9. Lysozyme Not less than 0.8 g/L10. Fucose Not less than 1.3 g/L11. Glucosamine Not less than 0.7 g/L12. Inositol Not less than 0.39 g/L13. Citric acid Not less than 0.35 g/L14. Cholesterol Not less than 88 mg/L15. Lipid Phosphorus Not less than 7 mg/L16. Prostaglandins Not less than PGE 150 mg/L

Not less than PGF 400 mg/L

When any of these nutrients is added, the amount of these added nutrients shall be declared on the label,which should be not less than mentioned. It may contain medium chain triglycerides, taurine, molybdenum andchromium.

The source of Mineral Salts and Vitamin Compounds may be used from:—

(1) Calcium (Ca) - Calcium carbonate, Calcium chloride, Calcium citrate, Calcium phosphate monobasic,Calcium phosphate dibasic, Calcium phosphate tribasic;

(2) Phosphorous (P) - Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphatetribasic, Magnesium phosphate dibasic, Potassium phosphate dibasic;

(3) Chloride (Cl) - Calcium chloride, Choline chloride, Magnesium chloride, Manganese chloride, Sodiumchloride, Sodium chloride iodized;

(4) Iron (Fe) - Ferrous citrate, Ferrous lactate, Ferrous sulphate, Ferric pyrophosphate;

(5) Magnesium (Mg) - Magnesium chloride, Magnesium oxide, Magnesium phosphate dibasic;

(6) Sodium (Na) - Sodium bicarbonate, Sodium chloride, Sodium chloride iodized, Sodium citrate, Sodiumphosphate monobasic;

(7) Potassium (K) - Potassium phosphate dibasic;

(8) Copper (Cu) - Cupric citrate, Cupric sulphate;

(9) Iodine (I) - Potassium iodide, Sodium iodide;

(10) Zinc (Zn) - Zinc sulphate;

(11) Source of Manganese (Mn) - Manganese chloride, Manganese sulphate.

Page 97: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

506 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Vitamins

(1) Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;(2) Provitamin A - Beta-carotene;(3) Vitamin D - Vitamin D2 - Ergocalciferol, Vitamin D3 - Cholecalciferol, Cholecalciferol-cholesterol;(4) Vitamin E - d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl-alpha-tocopheryl

acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;(5) Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamin mononitrate;(6) Riboflavin (Vitamin B2) - Riboflavin, Riboflavin 5' -phosphate sodium;(7) Niacin - Nicotinamide, Nicotinic acid;(8) Vitamin B6 - Pyridoxine hydrochloride;(9) Biotin (Vitamin H) - d-biotin;

(10) Folacin - Folic acid;(11) Pantothenic acid - Calcium pantothenate, Panthenol;(12) Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;(13) Vitamin K - Phytylmenaquinone;(14) Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;(15) Choline - Choline bitartrate, Choline chloride;(16) Inositol;(17) Selenium - Sodium selenite.

The product shall be free of lumps and shall be uniform in appearance. It shall be free from added starch,added colour and added flavour. It shall not have rancid taste and musty odour.

It may contain food additive listed below, —

Food Additives Maximum level in 100 ml of the ready-to-drink product

pH – adjusting agentsSodium hydroxide Limited by good manufacturing practice and within the limits forSodium hydrogen carbonate Sodium and Potassium in all types of infant formulaeSodium carbonatePotassium HydroxidePotassium hydrogenCarbonatePotassium CarbonateCalcium hydroxide

Sodium Citrate Limited by good manufacturing practice in allPotassium Citrate types of infant formulaeL (+) Lactic AcidL (+) Lactic acid producing culturesCitric Acid

Antioxidants 1 mg in all types of infant formulaeMixed tocopherols concentrate 0.4 gramand L-Ascorbyl palmitate

Mono and Diglycerides

Page 98: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 507

It shall conform to the following requirements namely:

1. Moisture, per cent by weight (not more than) 4.52. Total milk protein, per cent by weight (not less than) and 10.0

not more than 16.0

3. Total fat, percent by weight (not less than) 18.0Milk Fat, percent by weight (not less than) 12.0Linoleate per 100 gram (not less than) 1.398g

4. Total ash, per cent by weight (not more than) 8.55. Ash insoluble in dilute Hydrochloric acid, per cent by weight (not more than) 0.16. Solubility:

(a) Solubility Index maximum 2.0 ml(b) Solubility per cent by weight (not less than) 98.5

7. Vitamin A (as retinol) μg. per 100 g. (not less than) 350 μg8. Added Vitamin D (expressed as Cholecalciferol or Ergocalciferol) μg. per 100g. (not less than) 4.5 μg9. Vitamin C, mg per 100 g. (not less than) 35 mg10. Thiamine, μg per 100 g. (not less than) 185 μg11. Riboflavin, μg per 100 g. (not less than) 275 μg12. Niacin, μg per 100 g. (not less than) 1160 μg13. Pyridoxine μg per 100 g. (not less than) 160 μg14. Folic acid, μg per 100 g. (not less than) 20 μg15. Pantothenic acid, mg per 100 g. (not less than) 1.4 mg16. Vitamin B12, μg per 100 g. (not less than) 0.7 μg17. Choline, mg per 100 g. (not less than) 32 mg18. Vitamin K μg per 100 g. (not less than) 18 μg19. Biotin, μg per 100 g. (not less than) 7.0 μg20. Vitamin E (as a-tocopherol compounds) IU per 100g. (not less than) 3.15 IU21. Sodium mg per 100 g. (not less than) 90 mg22. Potassium, mg per 100 g. (not less than) 370 mg23. Chloride, mg per 100 g. (not less than) 250 mg24. Calcium, mg per 100 g. (not less than) 230 mg25. Phosphorous, mg per 100 g. (not less than) 115 mg26. Magnesium, mg per 100 g. (not less than) 22 mg27. Iron, mg per 100 g. (not less than) 5.0 mg28. Iodine, μg per 100 g. (not less than) 20 μg29. Copper, μg per 100 g. (not less than) 280 μg30. Zinc, mg per 100 g. (not less than) and 2.5 mg

not more than 5.0 mg31. Manganese, μg per 100g. (not less than) 20 μg32. Selenium, μg per 100 g. (not less than) 14 μg33. Bacterial count, per g. (not more than) 10,00034. Coliform count absent in 0.1 gram35. Yeast and mould count absent in 0.1 gram36. Salmonella and Shigella absent in 25 gram37. E. coli absent in 0.1 gram38. Staphylococcus aureas absent in 0.1 gram

Page 99: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

508 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Premature/Low birth weight infant milk substitutes—

Provided that the premature/low birth weight infant milk substitutes shall also meet the followingrequirement in addition to the requirements mentioned above:—

(1) Protein shall be 2.25 - 2.75 gram per 100 kcal

(2) Mineral contents shall not be less than 0.5 gram per 100 kcal. The Calcium: Phosphorous ratioshall be 2:1. The Sodium, Potassium and Chloride combined together shall be not less than 40 milliequivalent per Litre;

(3) Whey: Casein ratio shall be 60:40. Essential amino acids should include taurine, cystine,tyrosine and histidine;

Lactose free infant milk substitute

Lactose and sucrose free infant milk substitute Sucrose free infant milk substitute

Provided that the lactose free or lactose and sucrose free or sucrose free infant milk substitutes shallalso meet the following requirement in addition to the requirements mentioned in the standard, provided thatin these three products edible vegetable oil may be used in place of milk fat and lecithin may be used as anemulsifier:—

(1) Soy protein-based, lactose-free formula shall have soy-protein and carbohydrate as glucose,dextrose, dextrin/maltodextrin, maltose and/or sucrose;

(2) Lactose-free cow’s/buffalo’s milk-based formulas shall have carbohydrate as glucose, dextrose,dextrin/maltodextrin, maltose and sucrose.

Hypoallergenic infant milk substitutes

Provided that the Hypoallergenic infant milk substitutes shall also meet the following requirement inaddition to the requirements mentioned in the standard:—

(1) Protein shall be hydrolyzed whey or casein or;

(2) 100% free amino acids as a protein source;

It shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from filmor combination or any of the substrate made of Board paper, polyethylene, polyester metallised film or in sucha way to protect from deterioration. It shall be packed in nitrogen or a mixture of nitrogen and carbon dioxide.”

(3) Milk-cereal Based Complementary Food Milk-cereal based complementary food commonly called asweaning food or supplementary food means foods based on milk, cereal and/or legumes (pulses), soyabean, millets,nuts and edible oil seeds, processed to low moisture content and so fragmented as to permit dilution with water, milkor other suitable medium.

Milk-cereal based complementary food is intended to supplement the diet of infants after the age of sixmonths.

Milk cereal based complementary food are obtained from milk, variety of cereals, pulses, soyabean, millets,nuts and edible oil seeds after processing. It may contain edible vegetable oils, milk solid, various carbohydratessuch as sucrose, dextrose, dextrins/ maltodextrin, maltose and lactose, calcium salts; phosphates and citrates andother nutritionally significant minerals and vitamins. It shall contain a minimum of 10 per cent milk protein by weightof the product. It shall also contain minimum 5 per cent milk fat by weight. It shall not contain hydrogenated fatscontaining trans-fatty acids. It may contain fungal alfa amylase upto a maximum extent of 0.025 percent by weight,fruits and vegetables, egg or egg products. It may also include amino acids such as lysine, methionine, taurine,carnitine etc.

The source of Vitamin Compounds and Mineral Salts may be used from,—

(1) Calcium (Ca) - Calcium carbonate, Calcium phosphate tribasic, Calcium sulphate;(2) Phosphorous (P) - Calcium phosphate tribasic;(3) Chloride (Cl) - Sodium chloride;

Page 100: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 509

(4) Iron (Fe) - Hydrogen reduced iron, Electrolytic iron;(5) Magnesium (Mg) - Magnesium chloride, Magnesium oxide, Magnesium phosphate dibasic;(6) Sodium (Na) - Sodium chloride;(7) Zinc (Zn) - Zinc sulphate;

Vitamins

(1) Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;(2) Provitamin A - Beta-carotene;(3) Vitamin D - Vitamin D2 -Ergocalciferol, Vitamin D3 -Cholecalciferol, Cholecalciferol-cholesterol;(4) Vitamin E - d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl-alpha-tocopheryl

acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;(5) Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamine mononitrate;(6) Riboflavin (Vitamin B2) -Riboflavin, Riboflavin 5' -phosphate sodium;(7) Niacin - Nicotinamide, Nicotinic acid;(8) Vitamin B6 - Pyridoxine hydrochloride;(9) Biotin (Vitamin H) - d-biotin;(10) Folacin - Folic acid;(11) Pantothenic acid - Calcium pantothenate, Panthenol;(12) Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;(13) Vitamin K - Phytylmenaquinone;(14) Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;(15) Choline - Choline bitartrate, Choline chloride;(16) Inositol;(17) Selenium- Sodium selenite.

It shall be in the form of powder, small granules or flakes, free from lumps and shall be uniform in appearance.

It shall be free from dirt and extraneous matter and free from preservatives and added colour and flavour. Itshall be free from any material, which is harmful to human health.

It may contain the following additives, —

Emulsifiers Maximum level in 100 gm of the product on a dry weight basis

Lecithin 1.5 gmsMono and Diglycerides 1.5 gms

PH – adjusting agents

Sodium hydrogen carbonate Limited by good manufacturing practice within the limit forSodium carbonate sodiumSodium CitratePotassium hydrogen CarbonatePotassium CarbonatePotassium CitrateSodium HydroxideCalcium HydroxidePotassium HydroxideL (+) Lactic AcidCitric Acid

Page 101: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

510 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Emulsifiers Maximum level in 100 gm of the product on a dry weight basis

AntioxidantsMixed tocopherols concentrate

- Tocopherol 300 mg /kg fat, singly or in combinationL-Ascorbyl Palmitate 200mg / kg fat

It shall conform to the following requirements, namely:—1. Moisture, per cent by weight (not more than) 5.02. Total protein, per cent by weight (not less than) 15.03. Fat, per cent by weight (not less than) 7.54. Total Carbohydrate, per cent by weight (not less than) 55.05. Total ash, per cent by weight (not more than) 5.06. Ash insoluble in dilute Hydrochloric acid, per cent by weight (not more than) 0.17. Crude fibre (on dry basis) per cent by weight (not more than) 1.08. Vitamin A (as retinol) μg per 100 g. (not less than) 350 μg9. Added Vitamin D, μg per 100 g. (expressed as Cholecalciferol or Ergocalciferol (not less than) 5 μg10. Vitamin C, mg per 100 g. (not less than) 25 mg11. Thiamine (as hydrochloride), mg per 100 g. (not less than) 0.5 mg12. Riboflavin, mg per 100 g. (not less than) 0.3 mg13. Niacin, mg per 100 g. (not less than) 3.0 mg14. Folic acid μg per 100 g. (not less than) 20 μg15. Iron, mg per 100 g. (not less than) 5.0 mg16. Zinc mg per 100 g. (not less than) 2.5 mg

and not more than 5.0 mg17. Bacterial count, per g. (not more than) 10,00018. Coliform count absent in 0.1 gram19. Yeast and mould count absent in 0.1 gram20. Salmonella and Shigella absent in 25 gram21. E. coli absent in 0.1 gram22. Staphylococcus aureas absent in 0.1 gram

It shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from filmor combination or any of the substrate made of Board paper, polyethylene, polyester metallised film or in sucha way to protect from deterioration.(4) Processed Cereal Based Complementary Food commonly called as weaning food or supplementary food

means foods based on cereal and/or legumes (pulses), soyabean, millets, nuts and edible oil seeds, processed tolow moisture content and so fragmented as to permit dilution with water, milk or other suitable medium.

Processed cereal based complementary food are intended to supplement the diet of infants after the age of sixmonths and up to the age of two years.

Processed cereal based complementary food are obtained from variety of cereals, pulses, soyabean, millets,nuts and edible oil seeds after processing. It shall contain milled cereal and legumes combined not less than 75percent. Where the product is intended to be mixed with water before consumption, the minimum content of proteinshall not be less than 15% on a dry weight basis and the PER shall not be less than 70% of that of casein. The sodiumcontent of the products shall not exceed 100 mg/100 gram of the ready-to-eat product.

Hydrogenated fats containing trans-fatty acids shall not be added to the products. It may also containfollowing ingredients: - protein concentrates, essential amino acids (only natural L forms of amino acids shall beused), iodized salt; milk and milk products; eggs; edible vegetable oils and fats; fruits and vegetables; variouscarbohydrates such as sucrose, dextrose, dextrin, maltose dextrin, lactose, honey, corn syrup; malt; potatoes.

Page 102: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 511

The source of Vitamin Compounds and Mineral Salts may be used from,—

(1) Calcium (Ca) - Calcium carbonate, Calcium phosphate tribasic, Calcium sulphate;

(2) Phosphorous (P) - Calcium phosphate tribasic, Phosphoric acid;

(3) Chloride (Cl) - Sodium chloride, Hydrochloric acid;

(4) Iron (Fe) - Hydrogen reduced iron, Electrolytic iron;

(5) Sodium (Na) - Sodium chloride;

(6) Zinc (Zn) - Zinc acetate, Zinc chloride, Zinc oxide, Zinc sulphate;

Vitamins(1) Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;(2) Provitamin A - Beta-carotene;(3) Vitamin D - Vitamin D2 - Ergocalciferol, Vitamin D3 - Cholecalciferol, Cholecalciferol-cholesterol;(4) Vitamin E - d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl-alpha-

tocopheryl acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;(5) Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamine mononitrate;(6) Riboflavin (Vitamin B2) - Riboflavin, Riboflavin 5' -phosphate sodium;(7) Niacin - Nicotinamide, Nicotinic acid;(8) Vitamin B6 - Pyridoxine hydrochloride;(9) Biotin (Vitamin H) - d-biotin;(10) Folacin - Folic acid;(11) Pantothenic acid - Calcium pantothenate, Panthenol;(12) Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;(13) Vitamin K - Phytylmenaquinone;(14) Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;(15) Choline - Choline bitartrate, Choline chloride;(16) Inositol;(17) Selenium- Sodium selenite.

It shall be in the form of powder, small granules or flakes, free from lumps and shall be uniform in appearance.

All ingredients, including optional ingredients, shall be clean, safe, suitable and of good quality. It shall befree from preservatives, added colour and flavour.

It may contain the following food additives:—

Name of the Food Additives Maximum Level in a 100 g of Product on a dry weight basis

EmulsifiersLecithin 1.5 gramMono and Diglycerides 1.5 grampH Adjusting AgentsSodium hydrogen carbonate Limited by good manufacturing practice and within the limits for

sodiumPotassium hydrogen carbonate}Calcium carbonate} Limited by good manufacturing practiceL(+) lactic acid 1.5 gmCitric acid 2.5 gm

Page 103: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

512 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Name of the Food Additives Maximum Level in a 100 g of Product on a dry weight basis

Antioxidants

Mixed tocopherols concentrate}

Alpha-tocopherol} 300 mg/kg fat, singly or in combination

L-Ascorbyl palmitate 200 mg/kg fat

L-Ascorbic acid and its sodium and 50 mg, expressed as ascorbic acid and within limits for sodium

potassium salts

Enzymes

Malt carbohydrates Limited by good manufacturing practice

Leavening Agents

Ammonium carbonate}

Ammonium hydrogen carbonate} Limited by good manufacturing practice

It shall also conform to the following requirements namely:—

(1) Moisture, per cent by weight (not more than) 4.0

(2) Total protein, per cent by weight (not less than) 15.0

(3) Total Carbohydrate, per cent by weight (not less than) 55.0

(4) Total ash, per cent by weight (not more than) 5.0

(5) Ash insoluble in dilute Hydrochloric acid, per cent by weight (not more than) 0.1

(6) Crude fibre (on dry basis) per cent by weight (not more than) 1.0

(7) Vitamin A (as retinol) μg per 100 g. (not less than) 350 μg

(8) Added Vitamin D, μg per 100 g. (expressed as Cholecalciferol or Ergocalciferol(not less than) 5 μg

(9) Vitamin C, mg per 100 g. (not less than) 25 mg

(10) Thiamine (as hydrochloride), mg per 100 g. (not less than) 0.5 mg

(11) Riboflavin, mg per 100 g. (not less than) 0.3 mg

(12) Niacin, mg per 100 g. (not less than) 3.0 mg

(13) Folic acid μg per 100 g. (not less than) 20.0 μg

(14) Iron, mg per 100 g. (not less than) 5.0 mg

(15) Zinc mg per 100 g. (not less than) 2.5 mg

and not more than 5.0 mg

(16) Bacterial count, per g. (not more than) 10,000

(17) Coliform count absent in 0.1 gram

(18) Yeast and mould count absent in 0.1 gram

(19) Salmonella and Shigella absent in 25 gram

(20) E. coli absent in 0.1 gram

(21) Staphylococcus aureas absent in 0.1 gram

It shall be packed in hermetically sealed clean and sound containers or in flexible pack made from film orcombination of any or the substrate made of board paper, polyethylene, polyester, metalised film or aluminum foil insuch a way to protect from deterioration.”

Page 104: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 513

(5) Follow-Up Formula-Complementary Food” means the product prepared by spray drying of the milk of cowor buffalos or mixture thereof. It may contain vegetable protein. Follow-up formula based on milk shall be preparedfrom ingredients mentioned below except that a minimum of 3 gram per 100 available Calories (or 0.7 gram per 100kilojoules) of protein shall be derived from whole or skimmed milk as such, or with minor modification that does notsubstantially impair the vitamin or mineral content of the milk and which represents a minimum of 90% of the totalprotein.

Follow-up formula for use as a liquid part of the complementary diet for infants after the age of six months andup to the age of two years when prepared in accordance with the instructions for use, 100 ml of the ready-for-consumption product shall provide not less than 60 kcal (or 250 kJ) and not more than 85 kcal (or 355 kJ).

Follow-up formula shall contain the following nutrients indicated below:

(a) Protein - Not less than 3.0 gram per 100 available calories (or 0.7 gram per 100 available kilojoules).

Not more than 5.5 g per 100 available calories (or 1.3 g per 100 available kilojoules).

(Protein shall be of nutritional quality equivalent to that of casein or a greater quantity of other proteinin inverse proportion to its nutritional quality. The quality of the protein shall not be less than 85% of that ofcasein).

Essential amino acids may be added to follow-up formula to improve its nutritional value. Only L formsof amino acids shall be used.

(b) Fat - Not less than 4 g per 100 Calories (0.93 gram per 100 available kilojoules)

Not more than 6 gram per 100 calories (1.4 gram per 100 available kilojoules)

Linoleic acid (in the form of glyceride) - Not less than 310 mg(in the form per 100 Calories)(or 74.09 mg per 100 available of glyceride)

The products shall contain nutritionally available carbohydrates suitable for the feeding of the olderinfant and young child in such quantities as to adjust the product to the energy density in accordance withthe requirements given above.

It may also contain other nutrients when required to ensure that the product is suitable to form part ofa mixed feeding scheme intended for use after six months of age. When any of these nutrients is added, thefood shall contain not less than Recommended Dietary Allowances (RDA) amounts of these nutrients.

The source of Mineral Salts and Vitamin Compounds may be used from, —

(1) Calcium (Ca)-Calcium carbonate, Calcium chloride, Calcium citrate, Calcium phosphate monobasic,Calcium phosphate dibasic, Calcium phosphate tribasic;

(2) Phosphorous (P)- Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphatetribasic, Magnesium phosphate dibasic, Potassium phosphate dibasic;

(3) Chloride (Cl)-Calcium chloride, Choline chloride, Magnesium chloride, Manganese chloride,Sodium chloride, Sodium chloride iodized;

(4) Iron (Fe)- Ferrous citrate Ferrous lactate, Ferrous sulphate, Ferric pyrophosphate;(5) Magnesium (Mg)- Magnesium chloride, Magnesium oxide, Magnesium phosphate dibasic;

(6) Sodium (Na)- Sodium bicarbonate, Sodium chloride, Sodium chloride iodized, Sodium citrate,Sodium phosphate monobasic;

(7) Potassium (K)- Potassium phosphate dibasic;

(8) Copper (Cu)- Cupric citrate, Cupric sulphate;(9) Iodine (I)-Potassium iodide, Sodium iodide;

(10) Zinc (Zn)- Zinc sulphate;

(11) Source of Manganese (Mn)- Manganese chloride, Manganese sulphate.

Page 105: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

514 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Vitamins

(1) Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;

(2) Provitamin A - Beta-carotene;

(3) Vitamin D - Vitamin D2 - Ergocalciferol, Vitamin D3 - Cholecalciferol, Cholecalciferol-cholesterol;

(4) VitaminE-d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl-alpha-tocopheryl acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;

(5) Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamine mononitrate;

(6) Riboflavin (Vitamin B2) - Riboflavin, Riboflavin 5' -phosphate sodium;

(7) Niacin-Nicotinamide, Nicotinic acid;

(8) Vitamin B6 - Pyridoxine hydrochloride;

(9) Biotin (Vitamin H) - d-biotin;

(10) Folacin - Folic acid;

(11) Pantothenic acid - Calcium pantothenate, Panthenol;

(12) Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;

(13) Vitamin K - Phytylmenaquinone;

(14) Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;

(15) Choline - Choline bitartrate, Choline chloride;

(16) Inositol;

(17) Selenium - Sodium selenite.

The product shall be free of lumps and shall be uniform in appearance. It shall be free from added starch andadded colour and flavour. It shall not have rancid taste and musty odour.

It may contain the following additives, —

Maximum Level in 100 ml of Product Ready-for-Consumption

pH-Adjusting Agents

Sodium hydrogen carbonateSodium carbonateSodium citratePotassium hydrogen carbonatePotassium carbonatePotassium citrate Limited by good Manufacturing Practice within the limit for

sodiumSodium hydroxideCalcium hydorxidePotassium hydroxideL(+) Lactic acidCitric acid

Antioxidants

Mixed tocopherols concentrate3 mg singly or in combination

∝ - TocopherolL-Ascorbyl palmitate 5 mg singly or in combination.

Page 106: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 515

It shall also conform to the following requirements,—

S. No. Characteristics Requirements

1. Moisture, per cent by weight (not more than) 4.52. Total milk protein, per cent by weight (not less than) and 13.5

(not more than) 24.753. Total fat, per cent by weight (not less than) and 18.0

(not more than) 27.0Linoleate per 100 gm (not less than) 1.398

4. Total ash, per cent by weight (not more than) 8.55. Ash insoluble in dilute Hydrochloric acid, per cent by weight (not more than) 0.16. Solubility:

Solubility Index maximum 2.0 ml.Solubility per cent by weight (not less than) 98.5

7. Vitamin A (as retinol) μg per 100 g. (not less than) 350 μg8. Added Vitamin D (expressed as Cholecalciferol or Ergocalciferol)

μg per 100 g. (not less than) 4.5 μg9. Vitamin C, mg per 100 g. (not less than) 36 mg10. Thiamin, mcg per 100 g. (not less than) 180 μg11. Riboflavin, μg per 100 g. (not less than) 270 μg12. Niacin, μg per 100 g. (not less than) 1125μg13. Pyridoxine μg per 100 g. (not less than) 202.50 μg14. Folic acid, μg per 100 g. (not less than) 20.0 μg15. Pantothenic acid, mg per 100 g. (not less than) 1.35 mg16. Vitamin B12, μg per 100 g. (not less than) 0.675μg17. Choline, mg per 100 g. (not less than) 32 mg18. Vitamin K μg per 100 g. (not less than) 18μg19. Biotin, μg per 100 g. (not less than) 6.75μg20. Vitamin E (as a- tocopherol compounds) I.U. per 100g (not less than) 3.15 IU21. Sodium, mg per 100 g. (not less than) 90 mg22. Potassium, mg per 100 g. (not less than) 360 mg23. Chloride, mg per 100 g. (not less than) 247.50 mg24. Calcium, mg per 100 g. (not less than) 405 mg25. Phosphorous, mg per 100 g. (not less than) 270 mg26. Magnesium, mg per 100 g. (not less than) 27 mg27. Iron, mg per 100 g. (not less than) 5 mg28. Iodine, μg per 100 g. (not less than) 22.50μg29. Copper, μg per 100 g. (not less than) 280μg30. Zinc, mg per 100 g. (not less than) and 2.5 mg

(not more than) 5.0 mg31. Manganese, μg per 100 g. (not less than) 20μg32. Selenium, μg per 100 g. (not less than) 14μg33. Bacterial count, per g. (not more than) 10,00034. Coliform count absent in 0.1gram35. Yeast and mould count absent in 0.1gram36. Salmonella and Shigella absent in 25 gram37. E. coli absent in 0.1gram38. Staphylococcus aureas absent in 0.1gram

Page 107: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

516 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

It shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from film orcombination or any of the substrate made of Board paper, polyethylene, polyester metallised film or in such a wayto protect from deterioration. It shall be packed in nitrogen or a mixture of nitrogen and carbon dioxide.

Regulation 5.1.10: Butter, Ghee & Milk Fats

(1) Butter means the fatty product derived exclusively from milk of Cow and/or Buffalo or its productsprincipally in the form of an emulsion of the type water-in-oil. The product may be with or without added commonsalt and starter cultures of harmless lactic acid and / or flavour producing bacteria. Table butter shall be obtainedfrom pasteurised milk and/ or other milk products which have undergone adequate heat treatment to ensure microbialsafety. It shall be free from animal, body fat, vegetable oil and fat, mineral oil and added flavour. It shall have pleasanttaste and flavour free from off flavour and rancidity. It may contain food additives permitted in these Regulationsand Appendices. It shall conform to the microbiological requirements prescribed in Appendix B.

Provided that where butter is sold or offered for sale without any indication as to whether it is table or desibutter, the standards of table butter shall apply.

It shall conform to the following requirements:

Product Moisture Milk Fat Milk solids not Fat Commonsalt

Table Not more than Not more than Not more than 1.5 Not more than 3.0Butter 16.0 percent m/m 80.0 percent m/m percent m/m percent m/m

Desi – Not less thanCooking 76.0 percent m/m – –Butter

(2) Ghee means the pure clarified fat derived solely from milk or curd or from desi (cooking) butter or fromcream to which no colouring matter or preservative has been added. The standards of quality of ghee produced ina State or Union Territory specified in column 2 of the Table below shall be as specified against the said State orUnion Territory in the corresponding Columns 3,4,5 and 6 of the said Table.

S. Name of the State/ Butyro Minimum Percentage ofNo. Union Territory Refractometer Reichert FFA as oleic Moisture (Max.)

reading at 400C Value acid (max.)

(1) (2) (3) (4) (5) (6)

1. Andhra Pradesh 40.0 to 43.0 24 3 0.52. Andaman & Nicobar Islands 41.0 to 44.0 24 3 0.53. Arunachal Pradesh 40.0 to 43.0 26 3 0.54. Assam 40.0 to 43.0 26 3 0.55. Bihar 40.0 to 43.0 28 3 0.56. Chandigarh 40.0 to 43.0 28 3 0.57. Chattisgarh 40.0 to 44.0 26 3 0.58. Dadra and Nagar haveli 40.0 to 43.0 24 3 0.59. Delhi 40.0 to 43.0 28 3 0.510. (a) Goa 40.0 to 43.0 26 3 0.5

(b) Daman & Diu 40.0 to 43.5 24 3 0.511. Gujarat

(a) Areas other than cotton 40.0 to 43.5 24 3 0.5tract areas

(b) Cotton tract areas 41.5 to 45.0 21 3 0.5

Page 108: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 517

(1) (2) (3) (4) (5) (6)

12. Haryana(a) Areas other than cotton 40.0 to 43.0 28 3 0.5

tract areas(b) Cotton tract areas 40.0 to 43.0 26 3 0.5

13. Himachal Pradesh 40.0 to 43.0 26 3 0.514. Jammu & Kashmir 40.0 to 43.0 26 3 0.515. Jharkhand 40.0 to 43.0 28 3 0.516. Karnataka

(a) Areas other than 40.0 to 43.0 24 3 0.5 Belgaum district

(b) Belgaum district 40.0 to 44.0 26 3 0.517. Kerela 40.0 to 43.0 26 3 0.518. Lakshwadeep 40.0 to 43.0 26 3 0.519. Madhya Pradesh

(a) Areas other than cotton tract 40.0 to 44.0 26 3 0.5 areas

(b) Cotton tract areas 41.5 to 45.0 21 3 0.520. Maharashtra

(a) Areas other than cotton 40.0 to 43.0 26 3 0.5 tract areas

(b) Cotton tract areas 41.5 to 45.0 21 3 0.521. Manipur 40.0 to 43.0 26 3 0.522. Meghalya 40.0 to 43.0 26 3 0.523. Mizoram 40.0 to 43.0 26 3 0.524. Nagaland 40.0 to 43.0 26 3 0.525. Orisssa 40.0 to 43.0 26 3 0.526. Pondicherry 40.0 to 43.0 26 3 0.527. Punjab 40.0 to 43.0 28 3 0.528. Rajasthan

(a) Areas other than 40.0 to 43.0 26 3 0.5Jodhpur District

(b) Jodhpur district 41.5 to 45.0 21 3 0.5

29. Tamil Nadu 41.0 to 44.0 24 3 0.5

30. Tripura 40.0 to 43.0 26 3 0.5

31. Uttar Pradesh 40.0 to 43.0 26 3 0.5

32. Uttarakhand 40.0 to 43.0 26 3 0.5

33. West Bengal

(a) Areas other than 40.0 to 43.0 28 3 0.5 Bishnupur sub division

(b) Bishnupur sub division 41.5 to 45.0 21 3 0.5

34. Sikkim 40.0 to 43.0 28 3 0.5

Page 109: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

518 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Explanation.—By cotton tract is meant the areas in the States where cotton seed is extensively fed to thecattle and so notified by the State Government concerned.

(3) Milkfat / Butter oil and Anhydrous Milk fat / Anhydrous Butter oil means the fatty products derivedexclusively from milk and/ or products obtained from milk by means of process which result in almost total removalof water and milk solids not fat. It shall have pleasant taste and flavour free from off odour and rancidity. It shall befree from vegetable oil/ fat, animal body fat, mineral oil, added flavour and any other substance foreign to milk. It maycontain food additives permitted in these Regulations and Appendices. It shall conform to the microbiologicalrequirements prescribed in Appendix B. It shall conform to the following requirements:–

Requirements Milk fat/Butter Oil Anhydrous milk fat/ Anhydrous Butter Oil

(i) B.R reading at 40°C 40-44 40-44(ii) Moisture m/m Not more than 0.4 percent Not more than 0.1 percent(iii) Milk Fat m/m Not less than 99.6 percent Not less than 99.8 percent(iv) Reichert Value Not less than 24 Not less than 24(v) F.F.A as oleic acid Not more than 0.4 percent Not more than 0.3 percent(vi) Peroxide Value Not more than 0.6 percent Not more than 0.3 percent

(milli eqvt of Oxygen/ Kg fat)(vii) Boudouins Test Negative Negative

Regulation 5.1.11: CHAKKA & SHRIKHAND

(1) Chakka—means a white to pale yellow semi-solid product of good texture and uniform consistencyobtained by draining off the whey from the Yoghurt obtained by the lactic fermentation of cow’s milk, buffalo’s milk,skimmed milk and recombined or standardised milk which has been subjected to minimum heat treatment equivalentto that of pasteurisation. It shall have pleasant Yoghurt/Dahi like flavour. It shall not contain any ingredient foreignto milk. It shall be free from mouldness and free from signs of fat or water seepage or both. It shall be smooth and itshall not appear dry. It shall not contain extraneous colour and flavours. It shall conform to the following requirements,namely :—

Chakka Skimmed milk Chakka

(i) Total solids, per cent by weight Min. 30 Min. 20

(ii) Milk fat (on dry basis) Min. 33 Max.5per cent by weight

(iii) Milk protein (on dry basis) Min. 30 Min. 60per cent by weight

(iv) Titrable acidity (As lactic acid) per cent by weight Max. 2.5 Max. 2.5

(v) Total ash (on dry basis) per cent by weight Max. 3.5 Max. 5.0

Chakka when sold without any indication shall conform to the standards of Chakka.

(2) Shrikhand-means the product obtained from chakka or Skimmed Milk Chakka to which milk fat is added.It may contain fruits, nuts, sugar, cardamom, saffron and other spices. It shall not contain any added colouring andartificial flavouring substances. It shall conform to the following specifications, namely:—

(i) Total solids, per cent by weight Not less than 58(ii) Milk fat (on dry basis) per cent by weight Not less than 8.5(iii) Milk protein (on dry basis) per cent by weight Not less than 9(iv) Titrable acidity (on dry basis) per cent by weight Not more than1.4(v) Sugar (Sucrose) (on dry basis) per cent by weight Not more than 72.5(vi) Total ash (on dry basis) per cent by weight Not more than 0.9

Page 110: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 519

1 This standard for Yoghurt is currently in force, the revised standard vide GSR 356 (E) dated 7th June, 2005 is pending final approval andare currently deferred till 31st January, 2011

2 This is the revised standard for Yoghurt vide GSR 356 (E) dated 7th June, 2005, pending final approval and are currently deferred till31st January, 2011

In case of Fruits Shrikhand it shall contain Milk fat (on dry basis) per cent by weight... Not less than 7.0 andMilk Protein (on dry basis) per cent by weight... Not less than 9.0.

Regulation 5.1.12: Fermented Milk Products

(1) Yoghurt1 means a coagulated product obtained from toned milk, pasteurized or boiled milk by lactic acidfermentation through lactobacillus bulgaricus delbruckii var-bulgaricus and Streptococcus thermophillus. It mayalso contain cultures of Bifidobacterium bifidus and Lactobacillus acidophilus and if added, the declaration to thiseffect shall be made on the label. The product shall have smooth surface and custard like consistency with no wheyseparation. It may also contain –

(i) Milk powder, skimmed milk powder, whey powder, whey proteins, water soluble milk proteins,caseinmates, manufactured from pasteurized products and lactose enzyme preparation;

(ii) Sugar, corn-syrup or glucose syrup in case of sweetened, flavoured and fruit yoghurt only;(iii) Fruits, fruit pulp, jam, fruit syrup, fruit juice etc. in flavoured and fruit yoghurt only;(iv) Permitted colours and flavours in flavoured and fruit yoghurt only.

It may contain permitted stabilizers upto a maximum limit of 0.5 percent by weight. It shall also meet thefollowing requirements, namely:—

Yoghurt Yoghurt Yoghurt Fruit yoghurtPlain skimmed Sweetened and/

or flavoured

(i) Total milk solids percent by 13.5 11.0 13.5 10.0weight not less than

(ii) Milk fat, percent by weight, 3.0 0.5 3.0 1.5not less than

(iii) Sugar, percent by weight, - - 6.0 6.0not less than

(iv) Protein, percent by weight, 3.2 3.2 3.2 2.6not less than

Titrable acidity of the product shall be from 0.8 to 1.2 percent by weight (as lactic acid) The specified lacticacid bacterial count per gram of the product shall not be less than 10,00,000 and Escherichia. Coli shall be absent inthe product.

The type of yoghurt shall be clearly indicated on the label otherwise standard of Plain yoghurt shall apply.

Note – The yoghurt subjected to heat treatment after fermentation at temperature not less than 650C shall belabeled as “Thermised or Heat Treated Yoghurt” and shall conform to the above parameters except the minimumrequirement of specific lactic acid bacterial count per gm.

Yoghurt2 means a coagulated product obtained from pasteurised or boiled milk or concentrated milk, pasteurisedskimmed milk and /or pasteurised cream or a mixture of two or more of these products by lactic acid fermentationthrough the action of Lactobacillus bulgaricus and Steptococcus thermophilus. It may also contain cultures ofBifidobacterium bifidus and Lactobacillus acidophilus and if added a declaration to this effect shall be made on thelabel. The microorganisms in the final product must be viable and abundant. It may contain milk powder, skimmedmilk powder, unfermented buttermilk, concentrated whey, whey powder, whey protein, whey protein concentrate,water soluble milk proteins, edible casein, and caseinates manufactured from pasteurised products. It may alsocontain sugar, corn syrup or glucose syrup in sweetened yoghurt or fruits in fruits yoghurt. It shall have smoothsurface and thick consistency without separation of whey. It shall be free from vegetable oil/ fat, animal body fat,mineral oil and any other substance foreign to milk. The product may contain food additives permitted in Appendix

Page 111: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

520 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirements:—

Product Milk Fat Milk solids not fat Milk protein Sugar

(i) Yoghurt Not less than 3.0 Not less than 8.5 Not less than 3.2percent m/m percent m/m percent m/m –

(ii) Partly Not less than 0.5 Not less than 8.5 Not less than 3.2 –skimmed percent m/m & percent m/m percent m/mYoghurt Not more than

3.0 percent m/m

(iii) Skimmed Not more than Not less than 8.5 Not less than 3.2 –Yoghurt 0.5 percent m/m percent m/m percent m/m

(iv) Sweetened Not less than 3.0 Not less than 8.5 Not less than 3.2 Not less than 6.0Flavoured percent m/m percent m/m percent m/m percent m/mYoghurt

(v) Fruit Not less than 1.5 Not less than 8.5 Not less than 2.6 Not less than 6.0Yoghurt percent m/m percent m/m percent m/m percent m/m

Provided that Titrable acidity as lactic acid shall not be less than 0.85 percent and not more than 1.2 percent.The specific lactic acid producing bacterial count per gram shall not be less than 10,00,000. Provided further that thetype of Yoghurt shall be clearly indicated on the label otherwise standards of plain Yoghurt shall apply. The Yoghurtsubjected to heat treatment after fermentation at temperature not less than 65 degree C shall be labelled as Thermisedor Heat Treated Yoghurt and shall conform to the above parameters except the minimum requirement of specificlactic acid producing count per gram.

Regulation 5.1.13 : Whey Products

(1) Whey Powder means the product obtained by spray or roller drying sweet whey or acid whey from whichmajor portion of milk fat has been removed. Sweet Whey means the fluid separated from the curd after the coagulationof milk, cream, skimmed milk or buttermilk in the manufacture of cheese, casein or similar products, principally withnon-animal rennet type enzymes.

Acid Whey is obtained after coagulation of milk, cream, skimmed milk or buttermilk, principally with acids ofthe types used for manufacture of edible acid casein, chhana, paneer, or fresh cheese. It shall be of uniform colourwith pleasant taste and flavour free from off flavour and rancidity. It may contain food additives permitted inAppendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to thefollowing requirements:—

Requirements Whey Powder Acid Whey Powder

(i) Moisture Not more than 5.0 percent Not more than 4.5 percent

(ii) Milk Fat Not more than 2.0 percent m/m Not more than 2.0 percent m/m

(iii) Milk Protein (N x 6.38) Not less than 10.0 percent m/m Not less than 7.0 percent m/m

(iv) Total Ash Not more than 9.5 percent m/m Not more than 15.0 percent m/m

(v) pH (in 10.0% solution) Not less than 5.1 Not more than 5.1

(vi) Lactose content Not less than 61.0 percent m/m Not less than 61.0 percent m/mexpressed as anhydrousLactose

Note: (i) Although the powders may contain both anhydrous lactose and lactose monohydrates, the lactosecontent is expressed as anhydrous lactose.

(ii) 100 parts of lactose monohydrate contain 95 parts of anhydrous lactose.

Page 112: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 521

Regulation 5.1.14: Casein Products

(1) Edible Casein Products mean the products obtained by separating, washing and drying the coagulum ofskimmed milk.

(2) Edible acid casein means the product obtained by separating, washing and drying the acid precipitatedcoagulum of skimmed milk.

(3) Edible non-animal rennet casein means the product obtained after washing and drying the coagulumremaining after separating the whey from the skimmed milk which has been coagulated by non-animal rennet or byother coagulating enzymes

(4) Edible caseinate means the dry product obtained by reaction of edible casein or fresh casein curd with foodgrade neutralising agents and which have been subjected to an appropriate heat treatment. It shall be qualified bythe name of the cation and the drying process used (Spray or Roller dried).

The products shall be white to pale cream or have greenish tinge; free from lumps and any unpleasant foreignflavour, it may contain food additives permitted in these Regulations and Appendices. It shall conform to themicrobiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements Non-animal rennet Casein Acid Casein Caseinate

(i) Moisture Not more than 12.0 percent m/m Not more than 12.0 percent m/m Not more than 8.0 percent m/m

(ii) Milk Fat Not more than 2.0 percent m/m Not more than 2.0 percent m/m Not more than 2.0 percent m/m

(iii) Milk Protein (Nx6.38) Not less than 84.0percent m/m Not less than 90.0percent m/m Not less than 88.0percent m/m

(iv) Casein in Protein Not less than 95.0 percent m/m Not less than 95.0percent m/m Not less than 95.0percent m/m

(v) Ash including P2O5 Not less than 7.5 percent m/m Not more than 2.5percent m/m –

(vi) Lactose Not more than 1.0percent m/m Not more than 1.0 percent m/m Not more than 1.0 percent m/m

(vii) Free Acid ml – Not more than 0.27percent –0.1N NaOH / gm

(viii) pH Valuein 10% – – Not more than 8.0

Part 5.2: Fats, Oils And Fat Emulsions

Regulation 5.2.1 Definition(1) “De-oiled meal” means the residual material left over when oil is extracted by a solvent from any oil-

bearing material;

(2) “Hydrogenation” means the process of addition of hydrogen to an edible vegetable oil using acatalyst to produce a fat with semi-solid consistency;

(3) “Margarine” means an emulsion of edible oils and fats with water;

(4) “Refined vegetable oil” means any vegetable oil which is obtained by expression or solvent extractionof vegetable oil bearing materials, deacidified with alkali and/or by physical refining and/or by miscellarefining using permitted food grade solvents followed by bleaching with absorbent earth and/or activatedcarbon and deodorized with steam without using any other chemical agents

(5) “Refining” means a process by which an expressed vegetable oil or a solvent-extracted oil isdeacidified—

(i) With alkali, or(ii) by physical refining, or both, or(iii) By miscella refining using permitted food grade solvent, followed by bleaching with absorbent

earth and/or activated carbon or both of them and deodorized with steam without using any otherchemical agent;

(iv) refining includes the process of degumming using phosphoric acid

Page 113: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

522 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(6) “Solvent-extracted oil” means any vegetable oil obtained from oil-bearing material by the process ofextraction by a solvent;

(7) “Solvent-extracted edible flour” means the ground material obtained from specially prepared deoiledmeal, that is, the residual material left over when oil is extracted by a solvent from oil cake immediatelyfollowing the single-pressing of good quality edible oilseeds;

(8) “Vegetable oils” means oils produced from oilcakes or oilseeds or oil-bearing materials of plantorigin and containing glycerides;

(9) “Vegetable oil product” means any product obtained for edible purposes by subjecting one or moreedible oils to any or a combination of any of the processes or operations, namely, refining, blending,hydrogenation or interesterification and winterization (process by which edible fats and oils are fractionedthrough cooling), and includes any other process which may be notified by the Central Government in theofficial Gazette;

Regulation 5.2.2 OILS:

(1) Coconut Oil (Naryal Ka tel) means the oil expressed from copra obtained from the kernel of Cocosmucifera nuts. It shall be clear and free from rancidity, suspended or other foreign matter, separated water, addedcolouring or flavouring substances, or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40oC. 34.0 to 35.5

OrRefractive Index at 40oC 1.4481-1.4491Saponification value Not less than 250Iodine value 7.5 to 10.Polenske Value Not less than 13Unsaponifiable matter Not more than 1.0 per cent.Acid value Not more than 6.0 per cent.Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(2) Cotton Seed Oil (Binola Ka Tel) means the oil extracted from clean, sound delinted and decorticatedcotton seeds (genus Gossypium) It shall be refined. It shall be clear, free from rancidity, suspended or other foreignmatter, separated water, added colouring or flavouring substances or mineral oil. It shall conform to the followingstandards:—

Butyro-refractometerreading at 40oC. 55.6 to 60.2

OrRefractive Index at 40oC 1.4630-1.4660Saponification value 190 to 198Iodine value 98 to 112.Unsaponifiable matter Not more than 1.5 per cent.Acid value Not more than 0.50 per cent.There shall be no turbidity after keeping the filtered sample at 30oC for 24 hoursBellier Test (Turbidity temperature-Acetic acidmethod) 19.0 oC -21.0 oC

Page 114: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 523

Test for Argemone oil shall be negative

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(3) GROUNDNUT OIL (moongh-phali-ka tel) means the oil expressed from clean and sound groundnuts(Arachis hypogoes) It shall be clear, free from rancidity, suspended or other foreign matter, separated water addedcolouring or flavouring substances or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 54.0 to 57.1

OrRefractive Index at 40oC 1.4620-1.4640Saponification value 188 to 196Iodine value 85 to 99.Unsaponifiable matter Not more than 1.0 per cent.Acid value Not more than 6.0 percentBellier test Turbidity temperature Acetic acid method 39oC to 41oC

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(4) Linseed Oil (Tisi ka tel) means the oil obtained by process of expressing clean and sound linseed (Linumusitatissimum) It shall be clear, free from rancidity, suspended or other foreign matter, separated water, addedcolouring or flavouring substance, or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 69.5-74.3

OrRefractive Index at 40oC 1.4720-1.4750Saponification value 188 to 195Iodine value Not less than 170Unsaponifiable matter Not more than 1.5 per cent.Acid value Not more than 4.0 percent

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(5) Mahua Oil means the oil expressed from clean and sound seeds or nuts of Madhuca (Bassi latifolia or B.longifolia or a mixture of both) It shall be clear and shall be free from rancidity, suspended or other foreign matter,separated water, added colouring or flavouring substances, or mineral oil. It shall be refined and shall conform to thefollowing standards:—

Page 115: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

524 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Butyro-refractometerreading at 40 oC 49.5 to 52.7

OrRefractive Index at 40oC 1.4590 - 1.4611Saponification value 187 to 196Iodine value 58 to 70Unsaponifiable matter Not more than 2.0 per centAcid value Not more than 0.50 per cent

Test for argemone oil shall be negative

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(6) Rape-seed Oil (Toria Oil) Mustard Oil (Sarson ka tel) means the oil expressed from clean and soundmustard seeds, belonging to the compestris, juncea or napus varieties of Brassica. It shall be clear free fromrancidity, suspended or foreign matter, separated water, added colouring or flavouring substances or mineral oil. Itshall conform to the following standards:—

Butyro-refractometer reading at 40 oC 58.0 to 60.5Or

Refractive index at 40 oC 1.4646 to 1.4662Saponification value 168 to 177Iodine value 96-112:

Polybromide test shall be neagativeUnsaponifiable matter Not more than 1.2 per cent by weightAcid value Not more than 6.0 percentBellier test (Turbidity temperature – Acetic acid Method) 23.0 oC to 27.5 oCTest for Argemone oil NegativeTest for Hydrocyanic Acid Negative

Test for argemone oil shall be negative

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(7) Rapeseed or Mustard Oil - Low Erucic Acid means the oil obtained from clean and sound low erucic acidoil bearing seeds of rapeseed belonging to compestris, juncea, or napus varieties of Brassica by the method ofexpression or solvent extraction and it shall be clear, free from rancidity, suspended or other foreign matter, separatedwater, added colouring or flavouring substances or mineral oil and shall contain not more than 2 % erucic acid (as %of total fatty acids) and shall conform to the following standards, namely:—

Butyro-refractometer reading at 40 oC 58.6 to 61.7Or

Refractive index at 40 oC 1.465 to 1.467Iodine value (Wij’s method) 105 to 126Saponification value 182-193

Page 116: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 525

Unsaponifiable matter Not more than 20g/kgAcid value Not more than 0.6 percentBellier test (Turbidity temperature – Acetic acid Method) Not more than 19.0 oCTest for Argemone oil NegativeTest for Hydrocyanic Acid (Ferric Chloride test) Passes the test

Further, Rapeseed oil obtained by solvent extraction shall be supplied for human consumption only if it isrefined and it shall conform to the standard laid down under Regulation 5.2.2 (16) except acid value which shall benot more than 0.6. Additionally, it shall have Flash Point (Penske Marten Closed Method) not less than 250°C andthe oil so refined shall contain Hexane not more than 5.00 ppm :

Provided further that it may contain food additives permitted under these Regulations and Appendices”.

(8) Olive oil means the oil expressed from the fruit of the olive tree (Olea europaea sativa Hoffm. et Link) Itshall be of three types:—

(i) Virgin olive oil means the oil obtained from the fruit of the olive tree by mechanical or other physicalmeans under conditions, particularly thermal, which do not lead to alteration of the oil. Virgin olive oil is oilwhich is suitable for consumption in the natural state without refining. It shall be clear, yellow to green incolour, with specific odour and taste, free from odours or tastes indicating alteration or pollution of oil. It shallbe free from rancidity, suspended or other foreign matter, separated water, added colouring or flavouringsubstances or mineral oil.

(ii) Refined olive oil means the oil obtained from virgin olive, the acid content and or organolepticcharacteristics of which render it unsuitable for consumption in the natural state, by means of refiningmethods which do not lead to alterations in the initial glyceridic structure. It shall be clear, limpid withoutsediment, yellow in colour, without specific odour or taste and free from odours or taste indicating alterationor pollution of oil. It shall be free from rancidity, suspended or other foreign matter, separated water, addedcolouring or flavouring substances or mineral oil.

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refiningand shall conform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not containHexane more than 5.00 ppm.

(iii) Refined olive-pomace oil means the oil obtained from “olive pomace” by extraction by means ofsolvents and made edible by means of refining methods which do not lead to alteration in the initial glyceridicstructure. It shall be clear, limpid, without sediment, yellow to yellow-brown in colour, without specific odouror taste and free from odours or tastes indicating alteration or pollution of the oil. It shall be free from rancidity,suspended or other foreign matter, separated water, added colouring or flavouring substances or mineral oil.

However, it may contain food additives permitted in these Regulations and Appendices.

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) . The oil so refined shall not contain Hexane morethan 5.00 ppm

It shall conform to the following standards:–

Parameters Virgin olive oil Refined olive oil Refined olive—Pomace oil

B.R. Reading at 40ºC 51.0-55.6 51.0-55.6 51.6-55.9

OrRefractive Index at 40ºC 1.4600-1.4630 1.4600-1.4630 1.4604-1.4632Saponification value 184-196 184-196 182-193(mg KOH/g oil)Iodine value (wijs) 75-94 75-94 75-92

Page 117: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

526 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Parameters Virgin olive oil Refined olive oil Refined olive—Pomace oil

Unsaponifiable matter Not more than Not more than Not more than(using light petroleum) 15g/kg 15g/kg 30g/kgAcid Value Not more than 6.0 Not more than 5.0 Not more than 0.5Bellier test Not more than 17 Not more than 17 Not applicableSemi-Siccative oil test Negative Negative NegativeOlive pomace oil test Negative Negative NegativeCotton seed oil test Negative Negative NegativeTeaseed oil test Negative Negative NegativeSesame seed oil test Negative Negative NegativeTest for Argemone oil Negative Negative Negative

(9) Poppy Seed Oil means the oil expressed from poppy seeds (Papaver somniferum) It shall be clear, free fromrancidity, suspended or other foreign matter separated water, added colouring or flavouring substances or mineraloil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 60.0 to 64.0

OrRefractive Index at 40oC 1.4659 - 1.4685Saponification value 186 to 194Iodine value 133 to 143Unsaponifiable matter Not more than 1.0 per centAcid value Not more than 6.0

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(10) Safflower Seed Oil (barry Ka tel) means the oil expressed from the seeds of Carthamus tinctorius. It shallbe clear, free from rancidity, suspended or other foreign matter, separated water, added colouring or flavouringsubstances, or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 62.4 to 64.7

OrRefractive Index at 40oC 1.4674-1.4689Saponification value 186-196Iodine value 135-148Unsaponifiable matter Not more than 1.0 per centAcid value Not more than 6.0 percentBellier test Turbidity temperature Acetic acid method Not more than 16 oC

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

Page 118: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 527

10.1 Imported Safflowerseed oil and Safflowerseed oil (High Oleic Acid) means the oil expressed from theseeds of Carthamus tinctorious L. It shall be clear, free from rancidity, suspended or foreign matter, separated water,added colouring or flavouring substances, or mineral oil. It shall contain not less than 70% oleic acid as percent oftotal fatty acid. It shall conform to the following standards:–

Parameters High Oleic Acid Safflowerseed Oil Imported Safflowerseed OilB.R. Reading at 40ºC 51.0-57.1 61.7-66.4

OrRefractive Index at 40ºC 1.460-1.464 1.467-1.470Iodine value (wijs method) 80-100 136-148Saponification value 186-194 186-198Unsaponifiable matter Not more than 10g/kg Not more than 15g/kgAcid Value Not more than 4.0 mg/KOH/g oil Not more than 4.0 mg/KOH/g oilBellier test Turbidity Not more than 16 oC Not more than 16 oCtemperature Acetic acid methodTest for Argemone oil Negative Negative

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(11) Taramira Oil means the oil expressed from clean and sound seeds of Taramira (Eruca sativa) It shall beclear, free from rancidity, suspended or other foreign matter, separated water, added colouring or flavouringsubstances, or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 58.0 to 60.0

Or

Refractive Index at 40oC 1.4646-1.4659

Saponification value 174 to 177

Iodine value 99 to 105

Unsaponifiable matter Not more than 1.0 per cent

Acid value Not more than 6.0 percent

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(12) TIL OIL (Gingelly or sesame oil) means the oil expressed from clean and sounds of Til (Sesamumindicum), black, brown, white, or mixed. It shall be clear, free from rancidity, suspended or other foreign matter,separated water, added colouring or flavouring substances, or mineral oil. It shall conform to the followingstandards:—

Butyro-refractometerreading at 40 oC 58.0 to 61.0

OrRefractive Index at 40oC 1.4646-1.4665Saponification value 188-193

Page 119: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

528 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Iodine value 103-120Unsaponifiable matter Not more than 1.5 per centAcid value Not more than 6.0 percentBellier test Turbidity temperature Acetic acid method Not more than 22 oC

Provided that the oil obtained from white sesame seeds grown in Tripura, Assam and West Bengal shallconform to the following standards:—

Butyro-refractometerreading at 40 oC 60.5 to 65.4

Or

Refractive Index at 40oC 1.4662-1.4694

Saponification value 185 to 190

Iodine value 115 to 120

Acid value Not more than 6.0 percent

Unsaponifiable matter Not more than 2.5 per cent

Bellier test Turbidity temperature Acetic acid method Not more than 22 oC

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these regulations and Appendix A

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(13) Niger Seed Oil (Sargiya ka tel) means the edible oil obtained by process of expressing clean and soundseeds of Guizotia abyssinica. It shall be clear and free from rancidity, suspended or other foreign matter, separatedwater, added colouring or flavouring substances, mineral or other oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 61.0-65.0

Or

Refractive Index at 40oC 1.4665-1.4691

Saponification value 188-193

Iodine value 110 to 135

Unsaponifiable matter Not more than 1.0 per cent

Acid value Not more than 6.0 percent

Bellier test Turbidity temperature Acetic acid method 25 oC – 29 oC

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(14) Soyabean Oil means the oil expressed from clean and sound soyabeans (Soja max) from which the majorportion of the gums naturally present have been removed by hydration and mechanical or physical separation. It

Page 120: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 529

shall be clear, free from rancidity, suspended or other foreign matter, separated water added colouring or flavouringsubstances or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 58.5 to 68.0

Or

Refractive Index at 40oC 1.4649-1.4710

Saponification value 189 to 195

Iodine value 120 to 141

Unsaponifiable matter Not more than 1.5 per cent

Acid value Not more than 2.50 percent

Phosphorus Not more than 0.02 percent

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (15) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(15) Maize (Corn) Oil means the oil, extracted from the gram of clean and sound seeds of Zea Mays Linn. Fam.Graniniae, refined. It shall be free from rancidity, suspended or other foreign matter, separated water, added colouringor flavouring substances or Mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 56.7 to 62.5

Or

Refractive Index at 40oC 1.4637-1.4675

Saponification value 187 to 195

Iodine value 103 to 128

Unsaponifiable matter Not more than 1.5 per cent

Acid value Not more than 0.50 percent

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (15) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(16) Refined Vegetable Oil means any vegetable oil which is obtained by expression or solvent extraction ofvegetable oil bearing materials, deacidified with alkali and/or physical refining and/or by miscella refining usingpermitted foodgrade solvents followed by bleaching with absorbent earth and/or carbon and deodourised withsteam. No other chemical agent shall be used. The name of the vegetable oil from which the refined oil has beenmanufactured shall be clearly specified on the lable of the container. In addition to the under-mentioned standardsto which refined vegetable oils shall conform to the standards prescribed in these regulations for the specifiededible oils shall also apply except for acid value which shall be not more than 0.5. Moisture shall not exceed 0.10 percent by weight.

Page 121: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

530 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Test for argemone oil shall be negative.

(1) The refined vegetable oil shall be obtained from the following vegetable oils:

(i) Coconut Oil(ii) Cottonseed Oil(iii) Groundnut Oil(iv) Nigerseed Oil(v) Safflower Oil(vi) Sesame Oil(vii) Soyabean Oil(viii) Sunflower Oil

(ix) Mustard/Rapeseed Oil(x) Linseed Oil(xi) Mahua Oil(xii) Olive Oil(xiii) Poppyseed Oil(xiv) Taramira Oil(xv) Maize (Corn) oil(xvi) Watermelonseed Oil(xvii) Palm Oil(xviii) Palmolein

(xix) Palm Kernel Oil(xx) Rice Bran Oil(xxi) Salseed fat(xxii) Mango Kernel fat(xxiii) Kokum fat(xxiv) Dhupa fat(xxv) Phulwara fat

(2) The refined vegetable oil shall comply with the following requirements:

The oils shall be clear and free from rancidity, adulterants, sediments, suspended and other foreign matter,separated water, added colouring and flavouring substances and flavouring substances and mineral oil

(3) However, it may contain food additives permitted in these Regulations and Appendices

(17) Almond Oil means the oil expressed from he seeds of Prunus amygdalus Batach, var, dulcis Kochne(sweet almond) or of Prunus amygdalus Batach, var Amara Focke (bitter almond) without the application of heat. Itshall be clear from rancidity, suspended or other foreign matter, separated water, added colouring or flavouringsubstances or mineral oil. It shall conform to the following standards:—

Butyro-refractometerreading at 40 oC 54 to 57

OrRefractive Index at 40oC 1.4620-1.4639Saponification value 186 to 195Iodine value 90 to 109Acid value Not more than 6.0 percentBellier test Turbidity temperature Acetic acid method Not more than 60oC

Test for argemone oil shall be negative.

Page 122: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 531

However, it may contain food additives permitted in these Regulations and Appendices

(18) Water-melon Seed Oil means the oil extracted from the clean, sound seeds of the fruit of Water-Melon(Citrullus vulgaris Schrad, Family: cucurbitaceae) It shall be clear, free from rancidity, adulterants, sediments,suspended and other foreign matter, separated water, added colouring and flavouring substances and mineral oil. Itshall conform to the following standards:—

Moisture and volatile matter Not more than

0.25 per cent

Butyro-refractometerreading at 40 oC 55.6 - 61.7

Or

Refractive Index at 40oC 1.4630-1.4670

Saponification value 190 – 198

Iodine value 115 – 125

Acid value Not more than 6.0 percent

Unsaponifiable matter Not more than 1.5 per cent

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(19) Palm Oil- Palm oil means the oil obtained from fleshy mesocarp of fruits of the oil palm (Elaeis Guineensis)tree by the method of expression or solvent extraction. It shall be clear, free from rancidity, suspended or otherforeign matter, separated water, added colouring and flavouring substances or mineral oil. It shall conform to thefollowing standards, namely:—

Butyro-refractometerreading at 50 oC 35.5 - 44.0

Or

Refractive Index at 50 oC 1.4491-1.4552

Melting point (capillary slip method) Not more than 37 oC

Iodine value(Wij’s method) 45-56

Saponification value 195-205

Unsaponifiable matter Not more than 1.2 per cent

Acid value Not more than 10.0 percent

Indigenously produced raw Palm Oil obtained by method of expression may be supplied for human consumptionas such provided acid value is not more than 6.0 But palm oil imported into the country or produced by solventextraction shall be refined before it is supplied for human consumption and it shall conform to the standards laiddown under Regulation 5.2.2 (16) Additionally, it shall have Flash Point (Pensky-Marten closed method) - Not lessthan 250° C

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

The oil so refined shall not contain Hexane more than 5.00 ppm.

Page 123: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

532 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(20) Palmolein means the liquid fraction obtained by fractionation of palm oil obtained from the fleshymesocarp of fruits of oil palm (Elaeis Guineensis) tree by the method of expression or solvent extraction. It shall beclear, free from rancidity, suspended or other foreign matter separated water, added colouring and flavouringsubstances or mineral oils. It shall conform to the following standards, namely:—

Butyro-refractometer reading at 40 oC 43.7 - 52.5

Or

Refractive Index at 40 oC 1.4550 – 1.4610

Iodine value (Wij’s method) 54-62

Saponification value 195-205

Cloud Point Not more than 18oC

Unsaponifiable matter Not more than 1.2 per cent

Acid value Not more than 6.0 percent

Further, if the palmolein is obtained from solvent extracted palm oil, it shall be refined before it is supplied forhuman consumption and it shall conform to the standards laid down under Regulation 5.2.2 (16) Additionally, itshall have Flash Point (Penske Marten closed method) - not less than 250oC.

Test for argemone oil shall be negative. However, it may contain food additives permitted in these Regulationsand Appendices

The oil so refined shall not contain Hexane more than 5.00 ppm.

(21) Palm Kernel Oil means the oil obtained from sound kernel of the fruits of oil palm (Elaeis guinensis) treeby the method of expression or solvent extraction. It shall be clear, free from rancidity suspended, or other foreignmatter, separated water, added colouring and flavouring substances or mineral oil. It shall conform to the followingstandards, namely:—

Butyro-refractometerreading at 40 oC 35.1 - 39.5

Or

Refractive Index at 40 oC 1.4490 - 1.4520

Iodine value (Wij’s method) 10 – 23

Saponification value 237-255

Unsaponifiable matter Not more than 1.2 per cent

Acid value Not more than 6.0 percent

Further, if the oil is obtained by the method of solvent extraction, it shall be supplied for human consumptiononly after refining and shall conform to the standards laid down under Regulation 5.2.2 (16) Additionally, it shallhave Flash Point (Penske Marten closed method) - not less than 250oC.

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

The oil so refined shall not contain Hexane more than 5.00 ppm.

(22) Sun Flower Seed Oil means the oil obtained from clean and sound sunflower seeds or cake from theplants Helianthus annus linn (Family:compositae) by the method of expression or solvent extraction. It shall beclear, free from rancidity, suspended or other foreign matter, separated water, added colouring or flavouring substancesor mineral oil. It shall conform to the following standards, namely:—

Page 124: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 533

Butyro-refractometerreading at 40 oC 57.1 - 65.0

Or

Refractive Index at 40 oC 1.4640 - 1.4691

Iodine value (Wij’s method) 100 – 145

Saponification value 188-194

Unsaponifiable matter Not more than 1.5 per cent

Acid value Not more than 6.0 percent

Further, if the oil is obtained by the method of solvent extraction, it shall be supplied for human consumptiononly after refining and shall conform to the standards laid down under Regulation 5.2.2 (16) Additionally, it shallhave Flash Point (Penske Marten closed method) - not less than 250oC.

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

The oil so refined shall not contain Hexane more than 5.00 ppm.

22.01 Imported Sunflowerseed oil and Sunflowerseed oil (High Oleic Acid) means the oil obtained fromclean and sound Sunflowerseed or the High Oleic acid oil bearing Sunflowerseeds of Helianthus annuus L. by themethod of expression or solvent extraction. It shall be clear, free from rancidity, suspended foreign matter, separatedwater, added colouring or flavouring substance or mineral oil. It shall contain not less than 75% oleic acid as percentof total fatty acids. It shall conform to the following standards:–

Parameters High Oleic Acid Safflowerseed Oil Imported Safflowerseed Oil

B.R. Reading 61.7-68.0 at 25ºC 52.5-63.2 at 40ºC

Or

Refractive Index 1.467-1.471 at 25ºC 1.461-1.468 at 40ºC

Iodine value (Wijs method) 78-90 118-141

Saponification value 182-194 188-194

Unsaponifiable matter Not more than Not more than

15g/kg 15g/kg

Acid Value Not more than 4.0 mg/KOH/g oil Not more than 4.0 mg/KOH/g oil

Test for Argemone oil Negative Negative

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(23) Rice Bran Oil means the oil obtained from the layer around the endosperm of rice obtained from paddyof Oryza Sativa Linn. Fam Gramineae which is removed during the process of rice milling and is generally known asrice bran.

Refined Rice Bran Oil shall be obtained from solvent extracted oil, neutralised with alkali, bleached withbleaching earth or activated carbon or both and deodorised with steam. Alternatively deacidification’ bleaching anddeodorisation may be done by physical means.

The oil shall be clear and free from rancidity, adulterants, sediments, suspended and other foreign matters,separated water and added colouring and flavouring substances. The clarity of the oil shall be judged by theabsence of turbidity after keeping the filtered sample at 35oC for 24 hrs. Rice Bran Oil shall be sold for human

Page 125: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

534 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

consumption only after refining. It shall conform to the following standards, namely:—

Moisture and Volatile Matter Not more than 0.1 percent by weight

Refractive Index at 40 oC 1.4600 - 1.4700

Or

Butyro-refractometer reading at 40 oC 51.0 – 66.4

Saponification value 180 – 195

Iodine value (Wij’s method 90 – 105

Acid value Not more than 0.5

Unsaponifiable matter, percent by weight

for chemically refined Not more than 3.5

for physically refined Not more than 4.5

Oryzanol Content Not less than 1.0

Flash Point (Penske Marten Closed method) Not less than 250 oC

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(24) Blended Edible Vegetable Oil means an admixture of any two edible vegetable oils where the proportionby weight of any edible vegetable oil used in the admixture is not less than 20 per cent. The individual oils in theblend shall conform to the respective standards prescribed by these regulations. The blend shall be clear, free fromrancidity, suspended or insoluble matter or any other foreign matter, separated water, added colouring matter,flavouring substances, mineral oil, or any other animal and non-edible oils, or fats, argemone oils, hydrocyanic acid,castor oil and tricresyl phosphate. It shall also conform to the following standards, namely:—

(a) Moisture and volatile matter not more than 0.2 per cent by weight;

(b) Acid value:—

Nature of oil Acid Value

(1) Both raw edible vegetable oils in the blend Not more than 6.0

(2) One raw edible vegetable oil (s) Not more than 5.0

and one refined vegetable oil (s) in the blend

(3) All refined edible vegetable oils in the blend Not more than 0.5

(4) Unsaponifiable matter—

(a) Blended with rice bran oil Not more than 3.0 percent by weight

(b) Blended with other edible vegetable oil Not more than 1.50 percent by weight

(5) Flash point (Penske Martin closed method) Not less then 250°C

Test for Argemone oil shall be negative

However, it may contain food additives permitted in these Regulations and Appendices

Page 126: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 535

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16)

The oil so refined shall not contain Hexane more than 5.00 ppm.

Regulation 5.2.3 Interesterified Vegetable Fat: means an edible fatty material that has been so treated as tobring about a rearrangement of fatty acid positions within the glyceride entities and hence a change in the physicalproperties like melting point, viscosity, specific gravity and the like with very little change in the constitution of thefatty acids themselves by a process of interesterification of the essentially neutral edible oil or fat, singly or inmixtures generally through the use of alkaline catalysts exemplified by sodium or potassium metals, or their ethoxidesor hydroxides in the form either of anhydrous powders or in anhydrous glycerol medium followed by such post-process steps as washing, bleaching and deodourisation, the last of which can be omitted if the interesterified fat isto be incorporated as part of the raw material for further processing in edible fat products.

The interesterified fat shall be clear, free from soap, flavouring substances, rancidity, suspended or otherforeign matter, separated water and mineral oil. It shall conform to the following standards, namely:—

(i) It shall not contain any harmful colouring, flavouring or any other matter deleterious to health;

(ii) No colour shall be added to interesterified fat unless so authorised by Government, but in no eventany colour resembling the colour of ghee shall be added;

(iii) If any flavour is used, it shall be distinct from that of ghee in accordance with a list of permissibleflavours and in such quantities as may be prescribed by Government:

Provided that diacetyl to the extent of not more than 4.0 ppm may be added to interesterified fatexclusively meant for consumption by the Armed Forces;

(iv) It shall not have moisture exceeding 0.25 per cent;

(v) The melting point as determined by capillary slip method shall be from 31oC to 41oC, both inclusive;

(vi) The Butyro-refractometer reading at 40oC, shall not be less than 48 or Refractive Index at 40oC shallnot be less than 1.4580;

(vii) It shall not have unsaponifiable matter exceeding 2.0 per cent;

(viii) It shall not have free fatty acids (calculated as Oleic acid) exceeding 0.25 per cent;

(ix) The product on melting shall be clear in appearance and shall be free from staleness or rancidity, andpleasant to taste and smell;

(x) It shall contain raw or refined sesame (til) oil not less than 5 per cent by weight, but sufficient so thatwhen it is mixed with refined groundnut oil in the proportion of 20:80, the colour produced by the BaudouinTest shall not be lighter than 2.0 red units in a 1 cm. cell on a Lovibond scale;

(xi) It shall contain not less than 25 I.U. of synthetic Vitamin A per gram at the time of packing and shallshow a positive test for Vitamin A when tested by Antimony Trichloride (Carr-Price) reagent (As per IS: 5886-1970);

(xii) No anti-oxidant, synergist, emulsifier or any other such substance shall be added to it except withthe prior sanction of the Authority.

Test for argemone oil shall be negative.

However, it may contain food additives permitted in these Regulations and Appendices

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

Page 127: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

536 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 5.2.4 Partially Hydrogenated Soyabean Oil

(1) Partially Hydrogenated and Winterised Soyabean Oil means deodourised product obtained by light (mildor “Brush”) hydrogenation of degummed, deacidified, decolourised and winterised soyabean oil. The oil shall bedegummed by water with or without a food grade additive, deacidified by either neutralisation with alkali or steamdistillation (physical refining) or miscella refining using permitted food grade solvent, decolourised with bleachingearth and/or carbon, partially hydrogenerated using nickel catalyst, winterised with or without the use of a foodgrade solvent, filtered in a suitable filter press and deodourised with steam.

The product shall be clear, free from rancidity, suspended or other foreign matter, separated water, addedcolouring or flavouring substances, castor oil, mineral oil, and other vegetable and animal fats.

It may contain food additives permitted in these Regulations and Appendices.

It shall conform to the following standards:

Moisture Not more than 0.1 percent by weight

Refractive Index at 40 oC 1.4630 - 1.4690

OrButyro-refractometer reading at 40 oC 55.6 – 64.8Saponification value 189 – 195Iodine value (Wij’s method 107 – 120Acid value Not more than 0.50Unsaponifiable Matter Not more than 1.5 percent by weightLinolenic Acid (c18: 3) Not more than 3 percent by weightCloud Point (°C) Not less than 10°CFlash Point (Penske Marten Closed method) Not less than 250 oCTest for argemone oil shall be negative

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (15) The oil so refined shall not contain Hexane morethan 5.00 ppm.

(2) Partially Hydrogenated Soyabean Oil means deodourised product obtained by light (mild or “Brush”)hydrogenation of degummed, deacidified, deolourised soyabean oil. The oil shall be degummed by water with orwithout a food grade additive, deacidified by either neutralisation with alkali or steam distillation (physical refining)or miscella refining using permitted food grade solvent, decolourised with bleaching earth and/or carbon andpartially hydrogenated using nickel catalyst. The product shall again be deacidified, bleached and deodourised withsteam.

The product shall be clear liquid at 35 degree C. It shall be clear on melting, free from rancidity, suspended orother foreign matter, separated water, added colouring or flavouring substances, castor oil, mineral oil or othervegetable and animal facts.

It may contain food additives permitted in these Regulations and Appendices

It shall conform to the following standards:

Moisture Not more than 0.1 percent by weightRefractive Index at 40 oC 1.4630 - 1.4670

OrButyro-refractometer reading at 40 oC 55.6 – 61.7Saponification value 189 – 195Iodine value (Wij’s method 95 – 110

Page 128: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 537

Acid value Not more than 0.50Unsaponifiable Matter Not more than 1.5 percent by weightLinolenic Acid (c18: 3) Not more than 3 percent by weightCloud Point (°C) Not less than 25°CFlash Point (Penske Marten Closed method) Not less than 250 oC

Test for argemone oil shall be negative

Note :- The edible oils prescribed under Regulation 5.2.2 shall be free from Castor oil.

Further, if the oil is obtained by the method of solvent extraction and the oil imported into India whetherobtained by solvent extraction or otherwise, it shall be supplied for human consumption only after refining and shallconform to the standards laid down under Regulation 5.2.2 (16) The oil so refined shall not contain Hexane morethan 5.00 ppm.

Regulation 5.2.5 Edible Fats:

(1) Beef Fat Or Suet means fat obtained from a beef carcass. It shall have a Saponification value varying from193 to 200 and an Iodine value from 35 to 46.

It may contain food additives permitted in these Regulations and Appendices

(2) Mutton Fat means fat obtained from the carcass of sheep. It shall have a Saponification value varying from192 to 195 and an Iodine value from 35 to 46.

It may contain food additives permitted in these Regulations and Appendices

(3) Goat Fat means the rendered fat from goat. It shall have a Saponification value varying from 193 to 196 andIodine value from 36 to 45.

It may contain food additives permitted in these Regulations and Appendices

(4) Lard means the rendered fat from hogs and shall not contain more than one per cent of substances otherthan fatty acids and fat. It shall have a Saponification value varying from 192 to 198 and Iodine value from 52 to 65.

It may contain food additives permitted in these Regulations and Appendices

(5) Cocoa Butter means the fat obtained by expression from the nibs of the beans of Theobroma cocoa L. Itshall be free from other oils and fats, mineral oil and added colours. It shall conform to the following standards:

Percentage of free fatty acids (calculated as oleic acid) Not more than 1.5

Iodine value 32 to 42

Melting point 29o C to 34o C.

Butyro refractometer reading at 40oC

Or

Refractive Index at 40oC 40.9 to 48.0

1.4530-1.4580;

Saponification value 185 to 200

(6) Refined Salseed Fat means the fat obtained from seed kernels of Sal trees, shorea robusta Gaertn,f.(N.O.dipterocarpaceae) which has been neutralized with alkali, bleached with bleaching earth or activated carbonor both, and deodorised with steam, no other chemical agents being used. Alternatively, deacidification, bleachingand deodorisation may be done by physical means. The material shall be clear on melting and free from adulterants,sediment, suspended or other foreign matter, separated water or added colouring substance. However, it maycontain food additives permitted in these Regulations and Appendices. There shall be no turbidity after keeping thefiltered sample at 40oC for 24 hours. It shall conform to the following standards:—

Page 129: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

538 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(i) Moisture Not more than 0.1 percent(ii) Butyro refractometer reading at 400C 36.7 – 51.0

OrRefractive Index at 400C 1.4500 – 1.4600

(iii) Iodine Value (Wijs’ Method) 31 – 45(iv) Saponification value 180 – 195(v) Unsaponifiable matter Not more than 2.5 percent by weight(vi) Free fatty acids (expressed as Oleic acid)

OrAcid value Not more than 0.25 percent by weightNot more than 0.5

(vii) 9:10 epoxy and 9:10 Dihydroxy stearic acid Not more than 3.0 percent by weight(viii) Flash point (Pensky Marten closed method) Not less than 2500C

Test for argemone oil shall be negative

(7) Kokum Fat means the fat obtained from clean and sound kernels of Kokum (Garcinia indica choisy) “alsoknown as kokum, by process of expression or by a process of solvent extraction from cake or kernel. It shall berefined. The fat shall be clear on melting and free from rancidity, adulterants, sediments, suspended or other foreignmatter, separated water, added colouring and flavouring matters and mineral oil.” However, it may contain foodadditives permitted in these regulations and Appendix A.

It shall also conform to the following standards, namely:—

(a) Butyro-refractometer reading at 40o C, or 45.9—47.3Refractive Index at 40o C 1.4565 to 1.4575

(b) Saponification value 187—191.7(c) Unsaponifiable matters Not more than 1.5 per cent by weight(d) Iodine value (wijs) 32—40(e) Acid value Not more than 0.5(f) Flash Point

Pensky-Martens (closed) method Not less than 250o CTest for argemone oil shall be negative.

(8) Mango Kernel Fat means the fat obtained from clean and sound kernels of Mango (Magifera Indica Linn)by process of expression or by a process of solvent extraction from cake or kernel. It shall be refined. The fat shallbe clear on melting and free from rancidity, adulterants, sediment suspended or other foreign matter, separatedwater, added colouring and flavouring matters and mineral oil. However, it may contain food additives permitted inthese Regulations and Appendices.

It shall also conform to the following standards, namely :—(a) Butyro-refractometer reading at 400 C, 43.7—51.6

or Refractive Index at 400 C 1.4550 to 1.4604(b) Saponification value 185—198(c) Unsaponifiable matters Not more than 1.5 per cent by weight(d) Iodine value (wijs) 32—57(e) Acid value Not more than 0.5(f) Flash Point

Pensky-Martens (closed) method Not more than 250o CTest for argemone oil shall be negative.

Page 130: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 539

(9) Dhupa Fat means the fat obtained from clean and sound seed kernels of Dhupa, also known as IndianCopal (Vateria Indica Linn) tree by process of expression or by a process of solvent extraction from cake or kernel.It shall be refined. The fat shall be clear on melting and free from rancidity, adulterants, sediment, suspended or otherforeign matter, separated water, added colouring and flavouring matter and mineral oil. However, it may contain foodadditives permitted in these Regulations and Appendices

It shall also conform to the following standards, namely :—

(a) Butyro-refractometer reading at 400 C,or Refractive Index at 400 C 47.5—49.5

1.4576 to 1.4590(b) Saponification value 187—192(c) Unsaponifiable matters Not more than 1.5 per cent by weight.(d) Iodine value (wijs) 36—43(e) Acid value Not more than 0.5(f) Flash Point Not less than 2500 C

Penske-Martens (closed) method

Test for argemone oil shall be negative.

(10) Phulwara Fat means the fat obtained from clean and sound seed kernels of Phulwara [variously namedAisandra Butyrace (Roxb) Baelni, Madhuca Butyracea or Bassia Butyracea] by a process of expression or by aprocess of solvent extraction from cake or Kernel. It shall be refined. The fat shall be clear on melting and shall befree from rancidity, adulterants sediments, suspended on other foreign matters, separated water, added colouringand flavouring substances and mineral oil. However, it may contain food additives permitted in these Regulationsand Appendices.

It shall also conform to the following Standards, namely :—

(a) Butyro-refractometer reading at 400 C, 48.6—51.0or Refractive Index at 400 C 1.4584 to 1.4600

(b) Saponification value 192.5—199.4(c) Unsaponifiable matters Not more than 1.5 per cent by weight.(d) Iodine value (wijs) 43.8—47.4(e) Acid value Not more than 0.5(f) Flash Point Penske-Martens (closed) method Not less than 2500 C

Test for argemone oil shall be negative.

Regulation 5.2.6 Margarine And Fat Spreads:

(1) Table Margarine means an emulsion of edible oils and fats with water. It shall be free from rancidity, mineraloil and animal body fats. It may contain common salt not exceeding 2.5 per cent, skimmed milk powder not exceeding2 per cent; it may contain food additives permitted in these Regulations and Appendices. It shall conform to thefollowing specifications, namely:—

Fat Not less than 80 per cent mass/massMoisture Not less than 12 per cent and not more than 16 per cent mass/

mass.Vitamin A Not less than 30 I.U. per gram of the product at the time of sale.Melting point of extracted fat 310C to 370C(Capillary Sip Method)Unsaponifiable matter of extracted fat Not more than 1.5 per cent by weightFree fatty acids (as oleic acid) of extracted fat Not more than 0.25 per cent by weight

OrAcid Value Not more than 0.5

Page 131: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

540 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

It shall contain not less than 5.0 percent of its weight of Til oil but sufficient to ensure that when separated fatis mixed with refined groundnut oil in the proportion of 20:80 the red colour produced by the Baudouin test shall notbe lighter than 2.5 red units in 1 cm cell on a lovibond scale.

PROVIDED that such coloured and flavoured margarine shall also contain starch not less than 100 ppm andnot more than 150 ppm.

PROVIDED further that such coloured and flavoured margarine shall only be sold in sealed packages weighingnot more than 500gms.

Test for Argemone oil shall be negative

(2) Bakery and Industrial Margarine- means an emulsion of vegetable oil product with water. It shall be freefrom added colour and flavour, rancidity, mineral oil and animal body fats. It may contain common salt not exceeding2.5 percent. However, it may contain food additives permitted in these Regulations and Appendices. It shall conformto the following standards, namely:—

Fat Not less than 80 per cent m/m.

Moisture Not less than 12 per cent and Not more than 16 per cent m/m.

The separated fat of the products shall conform to the following :—

(i) Vitamin A Not less than 30 IU per gram at the time of packaging andshall show a positive test for Vitamin ‘A’ when tested byAntimony trichloride (carrprice) reagents (as per IS 5886-1970).

(ii) Melting point by Capillary slip method 31°C - 41°C

(iii) Unsaponifiable matter Not exceeding 2.0 per cent but incase of the products whereproportion of Rice bran oil is more than 30 per cent by wt. theunsaponifiable matter shall be not more than 2.5 per cent bywt. provided quantity of Rice bran oil is declared on the labelof such product as laid down in Regulation 4.4.5 (34).

(iv) Free Fatty Acidcalculated as Oleicacid Not more than 0.25 per cent.Not more than 0.5.or Acid value

It shall contain raw or refined sesame oil (Til oil) in sufficient quantity so that when the product is mixed withrefined groundnut oil in the proportion of 20 : 80, the colour produced by the Boudouin test shall not be lighter than2.0 red unit in a 1 cm. cell on a Lovibond scale.

Test for argemone oil shall be negative.

(3) Fat spread means a product in the form of water in oil emulsion, of an aquous phase and a fat phase ofedible oils and fats excluding animal body fats. The individual oil and fat used in the spread shall conform to therespective standards prescribed by these regulations.

Fat spread shall be classified into the following three groups:—

S.No. Types Characteristics

(a) Milk fat spread Fat content will be exclusively milk fat.

(b) Mixed fat spread Fat content will be a mixture of milk fat with any one or more ofhydrogenated, unhydrogenated refined edible vegetable Oils orinteresterified fat.

(c) Vegetable fat spread Fat content will be a mixture of any two or more ofhydrogenated,unhydrogenated refined vegetable oils or interesterfied fat.

The fat content shall be declared on the label. In mixed fat spread, the milk fat content shall also be declaredon the label alongwith the total fat content.

The word ‘butter’ will not be associated while labelling the product.

Page 132: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 541

It may ‘contain’ edible common salt not exceeding 2 per cent by weight in aqueous phase; milk solid not fat:It may contain food additives permitted in these Regulations and Appendices. It shall be free from animal body fat,mineral oil and wax. Vegetable fat spread shall contain raw or refined Sesame oil (Til oil) in sufficient quantity so thatwhen separated fat is mixed with refined groundnut oil in the proportion of 20:80 the red colour produced byBaudouin test shall not be lighter than 2.5 red units in 1 cm cell on a Lovibond scale.

It shall also conform to the following standards, namely:—

(i) Fat Not more than 80 per cent and not less than 40 per cent byweight.

(ii) Moisture Not more than 56 per cent and not less than 16 per cent byweight.

(iii) Melting point of Extracted fat (capillary slip Not more than 37oCmethod) in case of vegetable fat spread

(iv) Unsaponifiable matter of extracted fat

(a) In case of milk fat and mixed fat spread Not more than 1 per cent by weight

(b) In case of vegetable fat spread Not more than 1.5 per cent

(c) Acid value of extracted fat Not more than 0.5

(v) The vegetable fat spread shall contain Not less than 25 IU synthetic vitamin ‘A’ per gram at the timeof packing and shall show a positive test for vitamin ‘A’when tested by Antimony Trichloride (Carr-Price) reagents(as per I.S. 5886 — 1970)”.

(vi) It shall contain Starch Not less than 100 ppm andNot mor than 150 ppm

It shall be compulsorily sold in sealed packages weighing not more than 500g. under Agmark certificate mark.

Regulation 5.2.7 Hydrogenated Vegetable Oils

(1) Vanaspati means any refined edible vegetable oil or oils, subjected to a process of hydrogenation in anyform. It shall be prepared by hydrogenation from groundnut oil, cottonseed oil and sesame oil or mixtures thereof orany other harmless vegetable oils allowed by the government for the purpose. Refined sal seed fat, if used, shall notbe more than 10 per cent of the total oil mix. Vanaspati shall be prepared from one or more of the following vegetableoils:

(a) Coconut oil

(b) Cotton-seed oil

(c) Dhupa oil

(d) Groundnut oil

(e) Kokrum oil

(f) Linseed oil

(g) Mahua oil

(h) Maize (Corn) oil

(i) Mango kernel oil

(j) Mustard/Rape-seed oil

(k) Niger-seed oil

(l) Palm oil

(m) Phulwara oil

Page 133: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

542 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(n) Rice bran oil

(o) Sunflower (Kard/seed) oil

(p) Salseed oil (up to 10%)

(q) Sesame oil

(r) Soyabean oil

(s) Sunflower oil

(t) Watermelon seed oil

(u) Vegetable oils imported for edible purposes:

It shall conform to the standards specified below:—

(i) It shall not contain any harmful colouring, flavouring or any other matter deleterious to health;

(ii) No colour shall be added to hydrogenated vegetable oil unless so authorised by Government, but inno event any colour resembling the colour of ghee shall be added;

(iii) If any flavour is used, it shall be distinct from that of ghee in accordance with a list of permissibleflavours and in such quantities as may be prescribed by Government:

Provided that diacetyl to the extent of not more than 4.0 p.p.m. may be added to Vanaspati exclusivelymeant for consumption by the Armed Forces;

(iv) The product on melting shall be clear in appearance and shall be free from staleness or rancidity, andpleasant to taste and smell;

(v) It shall contain raw or refined sesame (til) oil in sufficient quantity so that when the vanaspati ismixed with refined groundnut oil in the proportion of 20:80, the colour produced by the Baudouin test shall notbe lighter than 2.0 red units in a 1 cm. cell on a Lovibond scale;

(vi) No anti-oxidant, synergist, emulsifier or any other substance shall be added to it except with theprior sanction of the Authority.

Provided that imported crude palm oil and fractions thereof shall not be used by the products other than thosewho are engaged in manufacture of vanaspati/any other hydrogenated oil produce and are equipped in the samelocation with the facilities for generation of hydrogen gas and hydrogenation of the said imported crude palm oiland fractions thereof with the gas so generated in the manufacture of vanaspati/any other hydrogenated vegetableoil product for edible consumption.

(vii) The product shall conform to the following requirements:

(a) Moisture, percent by mass: Not more than 0.25

(b) Melting point as determined by capillary slip method shall be from 31– 410C both inclusive

(c) it shall not have unsaponifiable matter exceeding 2.0 percent but in case of vanaspati whereproportion of rice bran oil is more than 30 peercent by weight, the unsaponifiable matter shall not bemore than 2.5 perent by weight provided quantity of rice bran is declared on the label of such vanaspatias laid down in Regulation 4.4.2(8)

(d) Free fatty acid (as oleic acid), percent by mass: Not more than 0.25

(e) Synthetic Vitamin ‘A’’: Not less than 25.0 International units (IU) per gram at the time ofpacking and shall test positive when tested with Antimony Trichloride (carr-Price Reagent) as perIS:5886-1970

(f) Residual Nickel: Not more than 1.5 ppm

(g) Test for argemone oil shall be negative.

(2) Bakery Shortening means vanaspati meant for use as a shortening or leavening agent in the manufactureof bakery products, that is, for promoting the development of the desired cellular structure in the bakery product

Page 134: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 543

with an accompanying increase in its tenderness and volume; this will also confirm to the standards prescribed inRegulation 5.2.7 (1) excepts that—

(a) the melting point as determined by the capillary slip method shall not exceed 41oC.(b) if aerated, only nitrogen, air or any other inert gas shall be used for the purpose and the quantity of

such gas incorporated in the product shall not exceed 12 per cent by volume thereof.(c) it may contain added mono-glycerides and diglycerides as emulsifying agents.

Test for argemone oil shall be negative.

PART 5.3: Fruit & Vegetable Products

Regulation 5.3.1: Thermally Processed Fruits

(1) Thermally Processed Fruits

(Canned/Bottled/Flexible packaged/Aseptically packed) means the products obtained from sound,matured, dehydrated, fresh or frozen, peeled or un-peeled, previously packed, whole, halves or cut pieces offruits packed with any suitable packing medium and processed by heat, in an appropriate manner, before orafter being sealed in a container, so as to prevent spoilage. It may contain water, fruit juice, dry or liquidnutritive sweeteners, spices and condiments and any other ingredients suitable to the product. The packingmedium alongwith its strength shall be declared on the label.

(2) The product may contain food additives permitted in these Regulations and Appendices. The productshall conform to the microbiological requirements given in Appendix B. Drained weight of fruits shall be not lessthan the weight given below:—

(i) Liquid pack Not less than 50.0 percent of net weight of the contents(ii) Solid Pack Not less than 70.0 percent of net weight of the contents

3. The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.2: Thermally Processed Fruit Cocktail / Tropical Fruit Cocktail

(1) Thermally Processed Fruit Cocktail / Tropical Fruit Cocktail (Canned, Bottled, Flexible Pack And / OrAseptically Packed) means the product prepared from a mixture of fruits which shall be declared on the label. Suchfruits may be fresh, frozen, dehydrated or previously processed. The fruit mixture may be packed with any suitablepacking medium and processed by heat in an appropriate manner before or after being sealed in a container so as toprevent spoilage. The packing medium alongwith its strength when packed shall be declared on the label.

(2) The name of the fruits used in the product and prepared in any style shall be declared on the labelalongwith the range of percentage of each fruit used in the product. The drained weight of fruits shall be not lessthan the weight given below:—

(a) Liquid pack 50.0 percent of net weight of contents(b) Solid Pack 70.0 percent of net weight of contents

(3) The product may contain food additives permitted in these Regulations and Appendices. The productshall conform to the microbiological requirements given in Appendix B. The container shall be well filled with theproduct and shall occupy not less than 90.0 percent of the net weight of the container, when packed in the rigidcontainers. The net weight of the container is the volume of distilled water at 20ºC which the sealed container iscapable of holding when completely filled.

Regulation 5.3.3: Thermally Processed Vegetables

(1) Thermally Processed Vegetables (Canned, Bottled/Flexible pack / Aseptically Packed) means the productobtained from fresh, dehydrated or frozen vegetables either singly or in combination with other vegetables, peeledor un-peeled, with or without the addition of water, common salt and nutritive sweeteners, spices and condiments orany other ingredients suitable to the product, packed with any suitable packing medium appropriate to the productprocessed by heat, in an appropriate manner, before or after being sealed in a container so as to prevent spoilage.

Page 135: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

544 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

The packing medium alongwith its strength shall be declared on the label. The product may be prepared in anysuitable style appropriate to the product. The product may contain food additives permitted in these Regulationsand Appendices. The product shall conform to the microbiological requirements given in Appendix B. The name ofthe vegetables used in the product and prepared in any style shall be declared on the label alongwith the range ofpercentage of each vegetable used in the product. Drained weight of vegetables shall be not less than the weightgiven below:—

(i) Liquid Pack

(a) Mushroom 50.0 percent of net weight of contents

(b) Green beans, carrots, peas, sweet corn/ baby corn 50.0 percent of net weight of contents

(c) Mushroon Packed in sauce 25.0 percent of net weight of contents

(d) Other Vegetables 50.0 percent of net weight of contents

(ii) Solid Pack 70.0 percent of net weight of contents

(2) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.4: Thermally Processed Curried Vegetables / Ready to Eat Vegetables

(1) Thermally Processed Curried Vegetables / Ready to Eat Vegetables means the product prepared fromfresh, dehydrated or frozen or previously processed vegetables, legumes, cereals or pulses, whether whole or cutinto pieces. The vegetable(s), either singly or in combination, may be prepared in any suitable style applicable forthe respective vegetable in normal culinary preparation. It may contain salt, nutritive sweeteners, spices andcondiments, edible vegetable oils and fats, milk fat and any other ingredients suitable to the product and processedby heat, in an appropriate manner, before or after being- in a container, so as to prevent spoilage.

(2) The product may contain food additives permitted in these Regulations and Appendices. The productshall conform to the microbiological requirements given in Appendix B.

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.5: Thermally Processed Vegetable soups

(1) Thermally Processed Vegetable Soups (Canned, Bottled, flexible pack And/ Or Aseptically Packed)means unfermented but fermentable product, intended for direct consumption, prepared from juice/ pulp/puree ofsound, mature vegetables, fresh, dehydrated, frozen or previously processed, singly or in combination, by blendingwith salt, nutritive sweeteners, spices and condiments and any other ingredients suitable to the product, cooked toa suitable consistency and processed by heat in an appropriate manner, before or after being sealed in a container,so as to prevent spoilage. It may be clear, turbid or cloudy.

(2) The product shall have total soluble solids (m/m) not less than 5.0 percent except for tomato soup whereit shall be not less than 7.0 percent (w/ w)

(3) The product may contain food additives permitted in these Regulations and Appendices. The productshall conform to the microbiological requirements given in Appendix B.

(4) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.6: Thermally Processed Fruits Juices

(1) Thermally Processed Fruits Juices (Canned, Bottled, Flexible And/Or Aseptically Packed) meansunfermented but fermentable product, pulpy, turbid or clear, intended for direct consumption obtained by a mechanicalprocess from sound, ripe fruit or the flesh thereof and processed by heat, in an appropriate manner, before or afterbeing sealed in a container, so as to prevent spoilage. The juice may have been concentrated and later reconstituted

Page 136: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 545

with water suitable for the purpose of maintaining the essential composition and quality factors of the juice. It maycontain salt. One or more of the nutritive sweeteners may be added in amounts not exceeding 50 g/kg but notexceeding 200g/kg in very acidic fruits. The product is not required to be called sweetened juice till the addednutritive sweeteners are not in excess of 15g/kg.

(2) The product may contain food additives permitted in these Regulations and Appendices. The productshall conform to the microbiological requirements given in Appendix B.

The product shall meet the following requirements:—

FRUIT JUICES

TSS Min( %) Acidity expressed as Added NutritiveCitric Acid Max.(%) Sweeteners Max

( g/kg)1 2 3 4

1. Apple Juice 10 3.5 (as malic acid) —2. Orange Juice

(a) Freshly expressed 10 3.5 50(b) Reconstituted from concentrate 10 3.5 —

3. Grape Fruit Juice 9 - 504. Lemon juice 6 4.0 2005. Lime juice - 5.0 200(6) Grape Juice

(a) Freshly expressed 15 3.5(b) Reconstituted from concentrate 15 3.5 —

(7) Pineapple Juicea) Freshly expressed 10 3.5 50b) Reconstituted from concentrate 10 3.5 —

(8) Black Current 11 3.5 200(9) Mango, Guava or any other pulp fruit 15 3.5 GMP(10) Other fruit juices of single species-

not very acidic 10 3.5 50(11) Other fruit juices of single species-

very acidic 10 3.5 200(12) Other fruit juices of single species or

combination thereof – not very acidic 10 3.5 50(13) Other fruit juices of single species or

combination thereof - very acidic 10 3.5 200

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.7 Thermally Processed Vegetable Juices

1. Thermally Processed Vegetable Juices (Canned, Bottled, Flexible Pack And/Or Aseptically Packed)means the unfermented but fermentable product or may be lactic acid fermented product intended for directconsumption obtained from the edible part of one or more vegetables, including roots, and tubers (e.g. carrots,garlic) stems & shoots (e.g. Asparagus), leaves & flowers (e.g. spinach and cauliflower) and legumes (e.g. peas)singly or in combination, may be clear, turbid or pulpy, may have been concentrated & reconstituted with watersuitable for the purpose of maintaining the essential composition & quality factors of the juice and processed byheat, in an appropriate manner, before or after being sealed in a container, so as to prevent spoilage. It may contain

Page 137: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

546 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

salt, nutritive sweeteners, spices and condiments, vinegar, whey or lactoserum having undergone lactic acidfermentation not more than 100 gm/kg and any other ingredients suitable to the product.

2. The product shall have total soluble solids free of added salts not less than 5.0 percent (w/w)

3. The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

4. The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.8 Thermally Processed Tomato Juice:

1. Thermally Processed Tomato Juice means the unfermented juice obtained by mechanical process fromtomatoes (Lycopersicum esculentus L) of proper maturity and processed by heat, in an appropriate manner, beforeor after being sealed in a container, so as to prevent spoilage. The juice may have been concentrated and reconstitutedwith water for the purpose of maintaining the essential composition and quality factors of the juice. The productmay contain salt and other ingredients suitable to the product. The product shall be free from skin, seeds and othercoarse parts of tomatoes. The product shall have pleasant taste and flavour characteristic of tomatoes free from offflavour and evidence of fermentation.

2. The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall conform to the requirements of Total SolubleSolids m/m free of added salt to be not less than 5.0 percent.

3. The container shall be well filled with the product and shall occupy not less than 90.0 percent of netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.9 Thermally Processed Fruit Nectars:

(1) Thermally Processed Fruit Nectars (Canned, Bottled, Flexible Pack And / Or Aseptically Packed) meansan unfermented but fermentable pulpy or non-pulpy, turbid or clear product intended for direct consumption madefrom fruit singly or in combination, obtained by blending the fruit juice / pulp/fruit juice concentrate and/ or ediblepart of sound, ripe fruit(s), concentrated or unconcentrated with water, nutritive sweeteners and any other ingredientappropriate to the product and processed by heat, in an appropriate manner, before or after being sealed in acontainer, so as to prevent spoilage.

(2) Lemon and Lime juice may be added as an acidifying agent in quantities which would not impair characteristicfruit flavour of the fruit used. The product may contain food additives permitted in Appendix A. The product shallconform to the microbiological requirements given in Appendix B. It shall meet the following requirements:—

Nectars of Citrus Juice TSS Min (%) Min. Fruit Juice Acidity Expressed asContent (%) Citric Acid Max (%)

Orange Nectar 15 40 1.5Grape Fruit Nectar 15 20 1.5Pineapple Nectar 15 40 1.5Mango Nectar 15 20 1.5Guava Nectar 15 20 1.5Peach Nectar 15 20 1.5Pear Nectar 15 20 1.5Apricot Nectar 15 20 1.5Non-pulpy Black Currant Nectar 15 20 1.5Other Fruit Nectar 15 20 1.5Other Fruit Nectars of High Acidity/Pulpy / 15 20 1.5Strong flavourMixed Fruit Nectar 15 20 1.5

Page 138: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 547

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.10: Thermally Processed Fruit Beverages / Fruit Drink/ Ready to Serve Fruit Beverages

1. Thermally Processed Fruit Beverages / Fruit Drink/ Ready to Serve Fruit Beverages (Canned, Bottled,Flexible Pack And/ Or Aseptically Packed) means an unfermented but fermentable product which is prepared fromjuice or Pulp/Puree or concentrated juice or pulp of sound mature fruit. The substances that may be added to fruitjuice or pulp are water, peel oil, fruit essences and flavours, salt, sugar, invert sugar, liquid glucose, milk and otheringredients appropriate to the product and processed by heat, in an appropriate manner, before or after being sealedin a container, so as to prevent spoilage.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall meet the following requirements:—

(i) Total Soluble solid (m/m) Not less than 10.0 percent

(ii) Fruit juice content (m/m)

(a) Lime/Lemon ready to serve beverage Not less than 5.0 percent

(b) All other beverage/drink Not less than 10.0 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.11: Thermally Processed Mango Pulp / Puree and Sweetened Mango Pulp / Puree

(1) Thermally Processed Mango Pulp / Puree and Sweetened Mango Pulp / Puree (Canned, Bottled, FlexiblePack And/ Or Aseptically Packed) means unfermented but fermentable product intended for direct consumptionobtained from edible portion of sound, ripe mangoes (Mangifera indica.L.), by sieving the prepared fruits, where as,the puree is obtained by finely dividing the pulp by a finisher or other mechanical means and processed by heat inan appropriate manner, before or after being sealed in a container, so as to prevent spoilage.

(2) It may contain one or more nutritive sweeteners in amounts not exceeding 50 gm/ kg. However, the productshall be described as sweetened Mango pulp/ puree if the amount of nutritive sweeteners is in excess of 15 gm / kg.

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble Solids (m/m)

(a) Sweetened Not less than 15.0 percent

(b) Unsweetened (Natural Mango Pulp) Not less than 12.0 percent

(ii) Acidity as Citric Acid (For sweetened canned mango pulp) Not less than 0.3 percent

(4) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.12 Thermally Processed Fruit Pulp / Puree And Sweetened Fruit Pulp / Puree other than Mango

(1) Thermally Processed Fruit Pulp / Puree And Sweetened Fruit Pulp / Puree other than Mango (Canned,Bottled, Flexible Pack And / Or Aseptically Packed) means unfermented but fermentable product intended fordirect consumption obtained from edible portion of sound, ripe fruit of any suitable kind & variety by sieving theprepared fruits, where as, the puree is obtained by finely dividing the pulp by a finisher or other mechanical meansand processed by heat in an appropriate manner, before or after being sealed in a container, so as to preventspoilage.

(2) It may contain one or more nutritive sweeteners in amounts not exceeding 50 gm/Kg. However, the productshall be described as sweetened pulp/puree if the amount of nutritive sweeteners is in excess of 15 gm. /kg.

Page 139: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

548 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble Solids (m/m) exclusive of added sugar Not less than 6.0 percent

(ii) Acidity as Citric Acid Not less than 0.3 percent

The container shall be filled with the product and shall occupy not less than 90.0 percent of the net weight ofthe container, when packed in the rigid containers. The net weight of the container is the volume of distilled waterat 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.13 Thermally Processed Concentrated Fruit / Vegetable Juice Pulp/ Puree

(1) Thermally Processed Concentrated Fruit / Vegetable Juice Pulp/ Puree (Canned, Bottled, Flexible PackAnd/ Or Aseptically Packed) means the unfermented product which is capable of fermentation, obtained from thejuice or pulp or puree of sound, ripe fruit(s) / vegetable(s), from which water has been removed to the extent that theproduct has a total soluble content of not less than double the content of the original juice/ pulp/ puree prescribedvide in Regulation 5.3.6 and 5.3.7. Natural volatile components may be restored to the concentrates where thesehave been removed. It may be pulpy, turbid or clear and preserved by heat, in an appropriate manner, before or afterbeing sealed in a container, so as to prevent spoilage.

(2) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.14 Thermally Processed Tomato Puree and Paste

(1) Thermally Processed Tomato Puree And Paste (Canned, Bottled, Flexible Pack And/ Or AsepticallyPacked) means unfermented product which is capable of fermentation, obtained by concentrating the juice ofsound ripe tomatoes to the desired concentration. It may contain salt and other ingredients suitable to the products.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

S.No. Product Total Soluble Solids (w/w)

1 Tomato puree Not less than 9.0 percent

2 Tomato Paste Not less than 25 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.15 Soup Powders:

(1) Soup Powders means the products obtained by mechanical dehydration of fresh vegetables/ fruits juice /pulp/puree of sound, vegetables / fruits and or earlier concentrated, dehydrated, frozen or processed fruits &vegetables, singly or in combination by blending with salt, nutritive sweeteners, spices and condiments and anyother ingredients suitable to the product, as appropriate to the product and packed suitably to prevent spoilage.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall comply with the following requirements:–

(i) Moisture (m/m) Not more than 5.0 percent

(ii) Total soluble solids (m/m) (on dilution on ready to serve basis) Not less than 5.0 percent

Regulation 5.3.16 Fruit/Vegetable Juice / Pulp/ Puree With Preservatives For Industrial Use only:

(1) Fruit/Vegetable Juice / Pulp/ Puree With Preservatives For Industrial Use only means an unfermentedbut fermentable product, pulpy, turbid or clear, obtained by a mechanical process from sound ripe fruits/ vegetables.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

Page 140: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 549

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.17 Concentrated Fruit Vegetable Juice /Pulp / Puree With Preservatives For Industrial UseOnly:

(1) Concentrated Fruit Vegetable Juice /Pulp / Puree With Preservatives For Industrial Use Only means anunfermented product, which is capable of fermentation, obtained from the juice or pulp or puree of fruit(s) / vegetable(s), from which the water has been removed to the extent that the product has a soluble solids content of not lessthan double the content of the original juice, pulp, puree prescribed under Regulation 5.3.6 and Regulation 5.3.7.It may be pulpy, turbid or clear.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.18 Tamarind Pulp/Puree and Concentrate:

(1) Tamarind Pulp/Puree And Concentrate means the unfermented product which is capable of fermentation,obtained from fresh or dried tamarind, by boiling with water and sieving it, and preserved either by thermal processingor by using permitted preservatives.

(2) The Tamarind Concentrate is the product obtained from tamarind pulp/ puree from which water has beenremoved by evaporation to achieve appropriate concentration.

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

Minimum TSS Percent Minimum Acidity Percent Ash Insoluble in diluteHCl Percent (Maximum)

Tamarind Pulp/Puree 32 4.5 0.4

Tamarind Concentrate 65 9.0 0.8

(4) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.19 Fruit Bar/ Toffee:

(1) Fruit Bar/ Toffee means the product prepared by blending Pulp/Puree from sound ripe fruit, fresh orpreviously preserved, nutritive sweeteners, butter or other edible vegetable fat or milk solids and other ingredientsappropriate to the product & dehydrated to form sheet which can be cut to desired shape or size.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall comply with the following requirements:—

(i) Moisture (m/m) Not more than 20.0 percent

(ii) Total soluble solids (m/m) Not less than 75.0 percent

(iii) Fruit content (m/m) Not less than 25.0 percent

Regulation 5.3.20 Fruit/Vegetable, Cereal Flakes:

(1) Fruit/Vegetable, Cereal Flakes means the product prepared by blending fruit(s) Pulp/Puree of sound ripefruit(s) / vegetables of any suitable variety, fresh, frozen or previously preserved, starch, cereals & nutritive sweeteners,other ingredients appropriate to the product with or without salt & dehydrated in the form of flakes.

Page 141: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

550 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall comply with the following requirements:—

(i) Moisture (m/m) Not more than 6.0 percent

(ii) Acid insoluble Ash (m/m) Not more than 0.5 percent

(iii) Starch (m/m) Not more than 25.0 percent

Regulation 5.3.21 Squashes, Crushes, Fruit Syrups/Fruit Sharbats and Barley Water:

(1) Squashes, Crushes, Fruit Syrups/Fruit Sharbats and Barley Water means the product prepared fromunfermented but fermentable fruit juice/puree or concentrate clear or cloudy, obtained from any suitable fruit orseveral fruits by blending it with nutritive sweeteners, water and with or without salt, aromatic herbs, peel oil andany other ingredients suitable to the products.

1.1 Cordial means a clear product free from any cellular matter, obtained by blending unfermented butfermentable clarified fruit juice with nutritive sweeteners & water with or without salt and peel oil and anyother ingredients suitable to the products.

1.2. Barley water means the product prepared from unfermented but fermentable fruit juice by blendingit with nutritive sweeteners, water with or without salt and peel oil and barley starch not less than 0.25 percentand any other ingredient suittable to the product.

1.3 The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall comply with the following requirements:—

Name of the products Min (%) of fruit juice/puree Total Soluble Solids Acidity expressed asin the final product (Min) % Citric Acid Max

(1) Squash 25 40 3.5

(2) Crush 25 55 3.5

(3) Fruit Syrup/Fruit Sharbats 25 65 3.5

(4) Cordial 25 30 3.5

(5) Barley Water 25 30 2.5

1.4 Any syrup/ sharbats containing a minimum of 10 percent of dry fruits shall also qualify to be called as fruitssyrups.

1.5 The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.22 Ginger Cocktail:

(1) Ginger Cocktail (Ginger Beer Or Gingerale) means the product prepared by blending ginger juice or itsoleoresin or essence with water and nutritive sweeteners.

(2) The product shall be free from extraneous matter. When suitably diluted shall have the colour and flavourcharacteristic of the product.

(3) The minimum total soluble solids shall not be less than 30.0 percent (m/ m)

(4) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

(5) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Page 142: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 551

Regulation 5.3.23 Synthetic Syrup for use in Dispensers for carbonated water:

(1) Synthetic Syrup for use in Dispensers for carbonated water means carbonated water obtained by blendingnutritive sweeteners with water and other ingredients appropriate to the product.

(2) The total soluble solid content (m/m) of the product shall not be less than 30 percent. The product whensuitably reconstituted shall conform to the requirements of carbonated water and match in all respects, exceptCarbon Dioxide contents, with similar product as bottled for direct consumption. It shall be free from extraneousmatter.

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

(4) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.24: SYnthetic Syrup or Sharbat

(1) Synthetic Syrup or Sharbat means the syrup obtained by blending syrup made from sugar, dextrose orliquid glucose.

It may also contain fruit juice and other ingredients appropriate to the product. It shall be free from burnt orobjectionable taints, flavours, artificial sweetening agents, extraneous matter and crystallization. It may containcitric acid, permitted colours, permitted preservatives and permitted flavouring agents. It shall also conform to thefollowing standards namely:—

Total soluble solids Not less than 65 per cent by weight

(2) DRIED GLUCOSE SYRUP means the material in the form of coarse or fine, white to creamish white powder,sweet to taste, bland in flavour and somewhat hygroscopic. It shall be free from fermentation, evidence of mouldgrowth, dirt or other extraneous matter or added sweetening or flavouring agent.

It shall also not contain any added natural or coaltar food colour. It shall conform to the following standards:—

Total solid contents Not less than 93.0 per cent by weight.

Reducing sugar content Not less than 20.0 per cent by weight.

Total Sugar as invert sugar Not more than 1.0 per cent by weight.

The product may contain food additives permitted in these Regulations and Appendices.

Regulation 5.3.25 Murabba

(1) Murabba means the product, prepared from suitable, sound whole or cut grated fruits, rhizome or vegetables,appropriately prepared, suitable for the purpose, singly or in combination, by impregnating it, with nutritivesweeteners to a concentration adequate to preserve it.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. The product shall conform to the following composition:

(i) Total soluble solids (m/m) Not less than 65.0 percent

(ii) Fruit contents (m/m) Not less than 55.0 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.26 Candied, Crystallised And Glazed Fruit / Vegetable / Rhizome / Fruit Peel:

1.1 Candied Fruits / Vegetables/ Rhizome / Fruit Peel means the product prepared from sound and ripe fruits,vegetables, rhizomes or fruit peel, of any suitable variety, appropriately prepared, by impregnating it with nutritivesweeteners to a concentration adequate to preserve it.

Page 143: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

552 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

1.2 Crystallised Fruit / Vegetable/ Rhizome / Fruit Peel means the product prepared from candied productby coating with pure crystallised sugar or by drying the syrup on wet candied fruit.

1.3 Glazed Fruit/ Vegetable/Rhizome / Fruit Peel means the product prepared from candied product bycoating it with a thin transparent layer of heavy syrup with or without pectin which has dried to a more or less firmtexture on the product.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:–

(i) The percentage of total sugar (w/w) Not less than 70.0

(ii) Percentage of reducing Sugar to total sugar Not less than 25.0

Regulation 5.3.27 Tomato Ketchup and Tomato Sauce:

(1) Tomato Ketchup and Tomato Sauce means the product prepared by blending tomato juice/Puree/Paste ofappropriate concentration with nutritive sweeteners, salt, vinegar, spices and condiments and any other ingredientssuitable to the product and heating to the required consistency. Tomato Paste may be used after dilution with watersuitable for the purpose of maintaining the essential composition of the product.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble solids (m/m) Salt free basis Not less than 25.0 percent

(ii) Acidity as acetic acid Not less than 1.0 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.28 Culinary Pastes / Fruits and Vegetable Sauces Other Than Tomato Sauce and Soya Sauce

(1) Culinary Pastes / Fruits and Vegetable Sauces Other Than Tomato Sauce and Soya Sauce means aculinary preparation used as an adjunct to food, prepared from edible portion of any suitable fruit/vegetableincluding, roots, tubers & rhizomes, their pulps/purees, dried fruits, singly or in combination by blending withnutritive sweeteners, salt, spices and condiments and other ingredient appropriate to the product.

(2) The product may contain food additives permitted in Appendix A. It may contain caramel but shall notcontain any other added colour whether natural or synthetic. The product shall conform to the microbiologicalrequirements given in Appendix B. It shall meet the following requirements:—

Name of the Product Total Soluble Solids (Salt free basis) (m/m) Acidity %(as acetic acid)

(i) Chilli Sauce Not less than 8.0 percent Not less than 1.0 percent

(ii) Fruits / Vegetable Sauces Not less than 15.0 percent Not less than 1.2 percent

(iii) Culinary Paste/ Sauce Not less than 8.0 percent Not less than 1.0 percent

(iv) Ginger Paste Not less than 3.0 percent Not less than 1.0 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.29 Soyabean Sauce:

(1) Soyabean Sauce means the product obtained from wholesome soyabeans, by fermenting the soyabeanpaste in which trypsin inhibitors have been inactivated & blending with salt, nutritive sweeteners. It may containspices and condiments and other ingredients appropriate to the product preserved by using permitted preservative.

Page 144: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 553

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble solids (m/m) Salt free basis Not less than 25.0 percent

(ii) Acidity as ascetic acid Not less than 0.6 percents

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.30 Carbonated Fruit Beverages or Fruit Drink:

(1) Carbonated Fruit Beverages or Fruit Drink means any beverage or drink which is purported to beprepared from fruit juice and water or carbonated water and containing sugar, dextrose, invert sugar or liquidglucose either singly or in combination. It may contain peel oil and fruit essences. It may also contain any otheringredients appropriate to the products.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble solids (m/m) Not less than 10.0 percent(ii) Fruit content (m/m)

(a) Lime or Lemon juice Not less than 5.0 percent(b) Other fruits Not less than 10.0 percent

(3) The product shall have the colour, taste & flavour characteristic of the product & shall be free fromextraneous matter.

(4) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.31: Jam

(1) Jam means the product prepared from sound, ripe, fresh, dehydrated, frozen or previously packed fruitsincluding fruit juices, fruit pulp, fruit juice concentrate or dry fruit by boiling its pieces or pulp or puree with nutritivesweeteners namely sugar, dextrose, invert sugar or liquid glucose to a suitable consistency. It may also contain fruitpieces and any other ingredients suitable to the products. It may be prepared from any of the suitable fruits, singlyor in combination. It shall have the flavour of the original fruit(s) and shall be free from burnt or objectionableflavours and crystallization.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirement:–

Total soluble solids (m/m) Not less than 65.0 percent

(3) The product shall be manufactured from not less than 45 percent, by weight, of original prepared, fruit,exclusive of any added sugar or optional ingredients of finished product except where fruit is strawberry or raspberrywhere it shall contain not less than 25 percent fruit.

Regulation 5.3.32 Fruit Jelly:(1) Fruit Jelly means the product prepared by boiling fruit juice or fruit (s) of sound quality, with or without

water, expressing and straining the juice, adding nutritive sweeteners, and concentrating to such a consistency thatgelatinisation takes place on cooling. The product shall not be syrupy, sticky or gummy and shall be clear, sparklingand transparent.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

Total soluble solids (m/m) Not less than 65.0 percent

(3) The product shall be manufactured from not less than 45 percent, by weight, of original prepared fruit,exclusive of any added sugar or optional ingredients of finished product.

Page 145: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

554 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 5.3.33 Fruit Cheese:

(1) Fruit Cheese means the product prepared from pulp/puree of sound, ripe fruit (s), whether fresh, frozen orpreviously preserved or dry fruits, by cooking with salt, nutritive sweeteners to attain a thick consistency so that itsets on cooling. Cheese shall be neither too soft nor too hard to chew. It may be prepared from any of the suitablefruits, singly or in combination. It shall have the flavour of the original fruit(s) and shall be free from burnt ofobjectionable flavours and crystallization.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirement:–

Total soluble solids (m/m) Not less than 65.0 percent

(3) The product shall be manufactured from not less than 45 percent by weight, of original prepared fruit,exclusive of any added sugar or optional ingredients of finished product except where fruit is strawberry or raspberrywhere it shall contain not less than 25 percent fruit.

Regulation 5.3.34 Marmalades:

(1) Marmalades means a product prepared by boiling sound fruits with peel, pulp and Juice, with or withoutwater, added nutritive sweeteners and concentrating to such a consistency that gelatinisation takes place oncooling of the product. It shall not be syrupy, sticky or gummy and shall be clear and transparent.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total soluble solids (m/m) Not less than 65.0 percent

(ii) Fruit content except peel (m/m) Not less than 45.0 percent

(iii) Peel in suspension Not less than 5.0 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20 degree C which the sealed container is capable of holding when completely filled.

Regulation 5.3.35 Dehydrated Fruits:

(1) Dehydrated Fruits means the product, prepared from edible part of suitable variety of sound fruit, free fromblemishes, insect or fungal infection, of appropriate maturity, from which, moisture has been removed, undercontrolled conditions of temperature, humidity and airflow, to the extent that the product is preserved.

(2) It may be whole, sliced, quarters, pieces or powdered. The finished product shall have uniform colour andshall be free from extraneous matter. The product shall have moisture content not more than 20 percent m/m. Whenin powder form, it shall be free flowing and free from agglomerates.

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

Regulation 5.3.36 Dehydrated Vegetables:

(1) Dehydrated Vegetables means the product, prepared from edible portions of suitable variety of soundvegetable, free from insect or fungal infection, free from blemishes, suitably prepared, from which moisture has beenremoved under controlled conditions of temperature, humidity & airflow, to the extent that the product is preserved.

(2) It may be whole, sliced, quarters, pieces, flakes, kibbled granules or powdered. The finished product shallhave uniform colour and shall be free from discolouration due to scorching or enzymatic reaction. It shall be freefrom stalks, peels, stems and extraneous matter. When in powder form, it shall be free flowing and free fromagglomerates.

(3) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the requirements as given in the Table below

Page 146: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 555

S. Name of Vegetables Moisture Sulphur Total Ash insoluble PeroxidaseNo. not more than Dioxide ash not dilute HCl Test

(percent) not more more not morethan (PPM) than than

( percent ) (percent)

1. Green Leafy Vegetables 7 2000 ppm - - Negative2. (a) Tubers like Arvi

(b) Lotus Root Tapioca(c) Yam(d) Carrot(e) Potato 7 2000 ppm - - Negative

3. Karela 6 - - - Negative4. Cabbage 6 2000 ppm - - Negative5. Okra 8 2000 ppm - - Negative6. Other Vegetables 8 2000 ppm 5 0.5 Negative7. Powders of Union and Garlic 5 - 5 0.5 Negative8. Powders of other vegetables 5 2000 ppm 5 0.5 Negative

including tomatoes

Regulation 5.3.37 Frozen Fruits/Fruit Products:

(1) Frozen Fruits/Fruit Products means the product frozen in blocks or individually quick frozen and offeredfor direct consumption, if required. Frozen Fruits/Fruit products are prepared from fresh, clean, sound, whole, fruitsof suitable maturity, free from insect or fungal infection, which are washed, sufficiently blanched to inactivateenzymes, if required, and are subjected to a freezing process in appropriate equipment. Freezing operation shall notbe regarded as complete unless and until the product temperature has reached (minus) - 18°C at the thermal centerafter thermal stablization. It may be prepared in any style appropriate for the respective Fruits/Fruit product innormal culinary preparation. It may contain salt, nutritive sweeteners, milk solids, spices and condiments and anyother ingredient suitable to the product.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B.

Regulation 5.3.38 Frozen Vegetables:

(1) Frozen Vegetables means the product frozen in blocks or individually quick frozen and offered for directconsumption, if required. Frozen vegetables are prepared from sound, clean vegetables of suitable maturity, freefrom insect or fungal infection, which are washed, sufficiently blanched to inactivate enzymes and are subjected toa freezing process in appropriate equipment. Freezing operation shall not be regarded as complete unless and untilthe product temperature has reached (minus) - 18°C at the thermal center after thermal stabilization. It may beprepared in any style appropriate for the respective vegetable in normal culinary preparation. It may contain salt,nutritive sweeteners, milk solids, spices and condiments and any other ingredient suitable to the product.

(2) It shall have normal colour characteristic of the individual Vegetable. It shall have taste & flavour characteristicof the kind & variety of the vegetable used & shall be free from sand, grit & other foreign matter.

(3) The product shall test negative for peroxidase. The product shall conform to the microbiological requirementsgiven in Appendix B.

Regulation 5.3.39 Frozen Curried Vegetables/Ready-to-Eat Vegetables:

(1) Frozen Curried Vegetables/Ready-to-Eat Vegetables means the product prepared from Fresh, Dehydratedor Frozen or previously processed vegetables, legumes, cereals or pulses, whether whole or cut into pieces.Vegetable(s) either singly or in combination may be prepared in any suitable style applicable for the respectivevegetables in normal culinary preparation. It may contain salt, nutritive sweeteners, spices and condiments, ediblevegetable oils and facts and milk fat and any other ingredients suitable to the product and subjected to freezing

Page 147: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

556 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

process in appropriate equipments. Freezing operation shall not be regarded as complete unless and until theproduct temperature has reached (minus) - 18°C at the thermal center after thermal sterilization.(2) The product shall conform to the microbiological requirements given in Appendix B.

Regulation 5.3.40 Fruit Based Beverage Mix/Powdered Fruit Based Beverage:

(1) Fruit Based Beverage Mix/Powdered Fruit Based Beverage means a product, in powder form, intendedfor use after dilution, obtained by blending fruit solids with nutritive sweeteners and other ingredients appropriateto the product & packed in hermetically sealed containers to prevent spoilage. It shall have colour & flavourcharacteristic of the named fruit. It may contain Vitamins and Minerals.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Moisture (m/m) Not more than 5.0 percent

(ii) Fruit juice content (m/m) when reconstituted by Not less than 5.0 percentdilution according to direction for use

Regulation 5.3.41 Fruits and Vegetable Chutney:

(1) Fruits and Vegetable Chutney means the product prepared from washed, clean, sound raw fruit(s) and / orvegetable(s) of any suitable variety, which have been peeled, sliced or chopped or shreded or comminuted andcooked with nutritive sweetener. It may contain salt, spices and condiments and any other ingredients suitable tothe product and preserved by thermal processing or other means.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total soluble solids (m/m)

(a) Fruit Chutney Not less than 50.0 percent

(b) Vegetable Chutney Not less than 25.0 percent

(c) Hot and Sour (Spicy Chutney) Not less than 25.0 percent

(ii) Fruits and Vegetable content (m/m) Not less than 40.0 percent

(iii) pH Not more than 4.6

(iv) Total ash (m/m) Not more than 5.0 percent

(v) Ash insoluble in hydrochloric acid (m/m) Not more than 0.5 percent

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20°C which the sealed container is capable of holding when completely filled. This requirementshall not be applicable for bulk packs for industrial use.

Regulation 5.3.42 Mango Chutney:

(1) Mango Chutney means the product prepared from washed clean sound mango (Mangifera indica L.) of anysuitable variety, which have been peeled, sliced or chopped or shreded or comminuted and cooked with nutritivesweeteners. It may contain Salt, Spices, Condiments and any other ingredient suitable to the product and preservedby thermal processing/ or other means.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Total Soluble solids (m/m) Not less than 50.0 percent(ii) Fruit content (m/m) Not less than 40.0 percent(iii) pH Not more than 4.6(iv) Total ash Not more than 5.0 percent(v) Ash insoluble in hydrochloric acid Not more than 0.5 percent

Page 148: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 557

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20ºC which the sealed container is capable of holding when completely filled.

Regulation 5.3.43 Pickles:

(1) Pickles means the preparation made from fruits or vegetables or other edible plant material includingmushrooms free from insect damage or fungal infection, singly or in combination preserved in salt, acid, sugar orany combination of the three. The pickle may contain onion, garlic, ginger, sugar jaggery, edible vegetable oil, greenor red chillies, spices, spice extracts/oil, limejuice, vinegar/ acetic acid, citric acid, dry fruits and nuts. It shall be freefrom copper, mineral acid, alum, synthetic colours and shall show no sign of fermentation.

(2) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. Pickles may be of combinations as given below:—

(i) Pickles in Citrus juice or Brine conforming to the following requirements:—

(a) Drained Weight Not less than 60.0 percent(b) Sodium Chloride content when packed in Brine Not less than 12.0 percent(c) Acidity as Citric Acid when packed In Citrus Juice Not less than 1.2 percent

(ii) Pickles in Oil(a) Drained Weight Not less than 60.0 percent(b) Fruit and Vegetable pieces shall be practically remaining submerged in oil

(iii) Pickles in Vinegar(a) Drained Weight Not less than 60.0 percent(b) Acidity of vinegar as acetic acid Not less than 2.0 percent

(iv) Pickle without medium means the pickles other than enumerated above. This may contain ingredientsgiven in Para 1 of this specification. Such pickles shall be labelled as “(give name of vegetable or fruits)Pickle”.

Regulation 5.3.44 Table Olives:

(1) Table Olives means the product obtained from sound clean fruits of proper maturity from Olive tree (Oleaeuropaea sativa Hoff of link) and suitably processed and preserved by natural fermentation / thermal processing orby addition of preservative. The product may be in the form of green olives, olives turning colour before completeripeness or black olives and may be whole, stoned (pitted) stuffed, halved, quartered, sliced, chopped, minced or inbroken form. The product may contain water, common salt, vinegar, olive oil, nutritive sweeteners and stuffingmaterial pimiento, onion, almond, celery, anchovy, olive, orange or lemon peel, hazelnut capers etc singly or incombination or in the form of a paste, spices, spice extracts and aromatic herbs. The product shall be of uniformcolour except seasoned olives and olives turning colour free from any foreign matter, off flavour and taste andabnormal fermentation. The product may contain food additive permitted in Appendix A. The product shall conformto the microbiological requirements given in Appendix B. It shall conform to the following requirements:—

Product in brine Sodium Chloride in brine PH of brine Acidity of brine aslactic acid

(a) Green olives treated /untreated – – –(i) in hermetically sealed containers Not less than 5.0 percent Not more than 4.0 –(ii) in non hermetically sealed containers Not less than 6.0 percent Not more than 4.5 –(iii) with natural lactic fermentation – – Not less than 0.4

Percent(b) Seasoned green olives – – –

(i) in hermetically sealed containers Not less than 4.0 percent Not more than 4.0 –(ii) in non hermetically sealed containers Not less than 6.0 percent Not more than 4.5 –

Page 149: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

558 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Product in brine Sodium Chloride in brine PH of brine Acidity of brine aslactic acid

(b) Olives turning colour – all Treatments Not less than 6.0 percent – –(d) Black Olives

(i) In brine Not less than 7.0 percent – –(ii) in dry salt Not less than 10.0 percent – –

(e) Damaged matter Not more than 2.0 percent by count(f) Insect damaged Units Not more than 2.0 percent by count(g) Foreign matter Not more than 1 unit per kg

Explanations:- For the purpose of this paragraph,—

‘Damage Units’ mean units showing imperfection or damage to the mesocarp which may or may not beassociated with superficial marks;

‘Insect Damaged Units’ means units showing insect holes or deformed fruits or those with abnormalstains or whose mesocarp has an abnormal aspect;

‘Foreign matter’ means any vegetable matter not injurious to health such as leaves, stem etc.

Regulation 5.3.45 Grated Desiccated Coconut:

(1) Grated Desiccated Coconut means the product obtained by peeling, milling and drying the kernel ofcoconut (cocos nucifera) The product may be in the form of thin flakes, chips or shreds. The product shall be whitein colour free from foreign matter, living insects, mould, dead insects, insect fragments and rodent contamination.The product shall have pleasant taste and flavour, free from rancidity and evidence of fermentation. The productmay contain food additives permitted in Appendix A. The products shall conform to the microbiological requirementsgiven in Appendix B. The product shall conform to the following requirements:—

(i) Extraneous Vegetable matter Not more than 15 units/100 gm(ii) Moisture (m/m) Not more than 3.0 percent(iii) Total Ash (m/m) Not more than 2.5 percent(iv) Oil Content (m/m) Not less than 55.0 percent(v) Acidity of extracted fat pressed as Lauric Acid (m/m) Not more than 0.3 percent(vi) Sulphur Dioxide Not more than 50.0 mg/kg

Explanation:– For the purpose of this paragraph Extraneous vegetable matter means fragments of shell, fibre,peel and burnt particles.

Regulation 5.3.46 VINEGAR:

(1) Brewed Vinegar means a product obtained by alcoholic and acetic acid fermentation of any suitablemedium such as fruits, malt (brewed exclusively from malted barley or other cereals), molasses, Jaggary, Sugar Canejuice etc. with or without addition of caramel and spices. It shall not be fortified with acetic acid.

(a) The product may contain food additives permitted in Appendix A. The product shall conform to themicrobiological requirements given in Appendix B. It shall meet the following requirements:—

(i) Acidity (m/v) Not less than 3.75 percent calculated as acetic Acid(ii) Total Solids (m/v) Not less than 1.5 percent(iii) Total ash content Not less than 0.18 percent(iv) It shall not contain sulphuric acid or any other mineral acid. It shall be free from any foreign substances

or colouring matter except caramel.

(b) The container shall be well filled with the product and shall occupy not less than 90.0 percent of thenet weight of the container, when packed in the rigid containers. The net weight of the container is the volumeof distilled water at 20°C which the sealed container is capable of holding when completely filled.

Page 150: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 559

(2) Synthetic Vinegar means the product prepared from acetic acid with or without caramel & spices and shallconfirm to the following requirements:

(i) Acidity of the product shall not be less than 3.75 percent m/v.

(ii) It shall not contain sulphuric acid or any other mineral acid. It shall be free from any foreign substanceor colouring matter except caramel.

(2) Synthetic vinegar shall be distinctly labelled as

SYNTHETIC - PREPARED FROM ACETIC ACID.

(3) The container shall be well filled with the product and shall occupy not less than 90.0 percent of the netweight of the container, when packed in the rigid containers. The net weight of the container is the volume ofdistilled water at 20°C which the sealed container is capable of holding when completely filled.

Regulation 5.3.47 Nuts & Raisins:

(1) Groundnut Kernel (deshelled) for direct human consumption commonly known as Moongphali are obtainedfrom the plant Arachis hypogols. The kernels shall be free from non-edible seeds such as mahua, caster, neem orargemone etc.

It shall be free from colouring matter and preservatives. It shall be practically free from extraneous matter, suchas stones, dirt, clay etc. The kernels shall conform to the following standards, namely:—

(i) Moisture Not more than 7.0 per cent

(ii) Damaged kernel including slightly damaged kernel Not more than 5.0 per cent by weight.

(iii) Aflatoxin content Not more than 30 parts per billion.

(2) Raisins means the product obtained by drying sound, clean grapes of proper maturity belonging to Vitisvinifera L. The product may be washed, with or without seeds and stems and may be bleached with Sulphur Dioxide.The product shall be free from foreign matter, living insects, mould, dead insects, insect fragments and rodentcontamination. The product shall have uniform colour, pleasant taste and flavour, free from odour and taste andevidence of fermentation. The product shall be free from added colouring matter. The product may contain foodadditives permitted in Appendix A. The product shall conform to the microbiological requirements given in AppendixB. The product shall conform to the following requirements:—

(i) Moisture (m/m) Not more than 15.0 percent

(ii) Damaged Raisins (m/m) Not more than 2.0 percent

(iii) Sugared Raisins (m/m) Not more than 15.0 percent

Explanation.- for the purpose of this paragraph,—

(i) ‘Damaged Raisins’ means raisins affected by sunburn, scars, mechanical injury which seriouslyaffects the appearance, edibility and keeping quality;

(ii) ‘Sugared Raisins’ means raisins with external or internal sugar crystals which are readily apparentand seriously affect the appearance of the raisins.

(3) Pistachio Nuts means the product obtained from mature seeds of Pistacia vera L which have been sundried and their shells opened naturally or mechanically. The product may be raw, roasted, salted and/or lime juicetreated. The product shall be free from foreign matter, living insects, mould, dead insects, insect fragments androdent contamination. The product shall have pleasant taste and flavour, free from odour and taste, mustiness andrancidity. The product shall be free from food additives. The product shall conform to the microbiological requirementsgiven in Appendix B. The product shall conform to the following requirements:—

(i) Moisture (m/m) Not more than 7.0 percent

(ii) Unopened Shells (m/m) Not more than 2.0 percent

(iii) Empty Shells (m/m) Not more than 1.0 percent

Explanation.-for the purpose of this paragraph,—

Page 151: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

560 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(i) ‘Unopened Shells’ means shells which are not split open but contain a fully developed kernel;

(ii) ‘Empty Shells’ means shells in which kernel is not developed;

(iii) ‘Mouldy Shells’ means nuts affected by mould.

(4) Dates means the product obtained by drying sound, clean fruits of proper maturity belonging to Phoenixdactylifera. The product may be washed, pitted or unpitted, with or without cap, pressed or loose. The product maybe treated with sugar, glucose syrup, flour and vegetable oil. The product shall be free from foreign matter, livinginsects, mould, dead insects, insect fragments and rodent contamination. The product shall have pleasant taste andsmell, free from odour and evidence of fermentation. The product shall be free from any added colouring matter. Theproduct may contain food additives permitted in Appendix A. The product shall conform to the microbiologicalrequirements given in Appendix B. The product shall conform to the following requirements:—

(i) Moisture (m/m) Not more than 30.0 percent

(ii) Ash insoluble in dil Hcl Not more than 0.1 percent

(iii) Blemished / Damaged Units Not more than 5.0 percent

(iv) Extraneous matter Not more than 1.0 percent

Explanation: - For the purpose of this paragraph —

(i) ‘Blemished’ means units showing scars, discoloration, sun burn, dark spots on the surface;

(ii) ‘Damaged’ means dates affected by mashing and/ or tearing of the flesh exposing the pit or significantlychanging the appearance.

(iii) ‘Extraneous vegetable matter’ means stalks, pieces of shells, pits, fibre, peel, etc.

(5) Dry Fruits and Nuts means the products obtained by drying sound, clean fruits and nuts of propermaturity. The product may be with or without stalks, shelled or unshelled, pitted or unpitted or pressed into blocks.The product shall be free from mould, living / dead insects, insect fragments and rodent contamination. The productshall be uniform in colour with a pleasant taste and flavour characteristic of the fruit/ nut free from off flavour,mustiness, rancidity and evidence of fermentation. The product shall be free from added colouring. The productshall conform to the following requirements:—

(i) Extraneous Vegetable matter (m/m) Not more than 1.0 percent

(ii) Damaged/ Discoloured units (m/m) Not more than 2.0 percent

(iii) Acidity of extracted fat expressed as oleic Acid Not more than 1.25 percent

Explanation - For the purpose of this paragraph —

(i) ‘Extraneous vegetable matter’ means stalks, pieces of shells, pits, fibre, peel;

(ii) ‘Damaged or Discoloured’ means units affected by sunburn, scars mechanical injury, discolourationand insects.

Regulation 5.3.48 BEAN: means dry kidney shaped or flattened seeds of the leguminous varieties used as food,either whole or prepared as dal. It shall not contain hydrocyanic acid exceeding 20 parts per million as determined by A.O.A.C. Maceration method.

PART 5.4 : Cereals & Cereal Products

Regulation 5.4.1 Atta

(1) Atta Or Resultant Atta means the coarse product obtained by milling or grinding clean wheat free fromrodent hair and excreta It shall conform to the following standards:—

Moisture Not more than 14.0 per cent (when determined byheating at 130-133oC for 2 hours).

Total ash Not more than 2.0 per cent (on dry weight basis).

Ash insoluble in dilute HCl Not more than 0.15 percent (on dry weight basis).

Page 152: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 561

Gluten (on dry weight basis). Not less than 6.0 per cent

Alcoholic acidity (with 90 per cent alcohol) expressed Not more than 0.18 per centas H2SO4 (on dry weight basis)

It shall be free from rodent hair and excreta

(2) Fortified Atta means the product obtained by adding one or more of the following materials to atta,namely:—

(a) Calcium carbonate (prepared chalk, popularly known as Creta preparata)

(b) Iron

(c) Thiamine

(d) Riboflavin, and

(e) Niacin.

The calcium carbonate powder, if added for fortification shall be in such amount that 100 parts by weight offortified atta shall contain not less than 0.30 and not more than 0.35 parts by weight of calcium carbonate. It shall befree from Rodent hair and excreta

(3) Protein Rich (Paushtik) Atta means the product obtained by mixing wheat atta with groundnut “or Soyaflour”, or a combination of both”. flour up to an extent of 10.0 per cent. Soya flour which is a solvent extracted soyaflour used in such mix shall conform to the standards of Soya flour laid down under Regulation 5.4.13 (1) It shall befree from insect or fungus infestation, odour and rancid taste. It shall not contain added flavouring and colouringagents or any other extraneous matter. It shall conform to the following standards:—

Moisture Not more than 14.0 per centTotal ash Not more than 2.75 per cent on dry basis.Ash insoluble in dilute HCl Not more than 0.1 percent on dry basis.Total Protein (N x 6.25) Not less than 12.5 percent on dry basisCrude Fibre Not more than 2.5 per cent on dry basisAlcoholic acidity (with 90 per cent alcohol) expressed Not more than 0.12 per centas H2SO4

It shall be free from Rodent hair and excreta

Regulation 5.4.2 Maida:

(1) Maida means the fine product made by milling or grinding clean wheat free from rodent hair and excreta andbolting or dressing the resulting wheat meal. It shall conform to the following standards:—

Moisture Not more than 14.0 per cent(when determined by heating at 130-133oC for 2 hours).Total ash Not more than 1.0 per cent (on dry weight basis).Ash insoluble in dilute HCl Not more than 0.1 percent (on dry weight basis).Gluten (on dry weight basis). Not less than 7.5 per centAlcoholic acidity (with 90 per cent alcohol) expressed Not more than 0.12 per centas H2SO4 (on dry weight basis)

It shall be free from Rodent hair and excreta.

If the product is to be used for bakery purpose, the following flour treatment agents in the quantities mentionedagainst each may be used, namely:—

Benzoyl peroxide (Max) 40 p.p.m.

Potassium bromate (Max) 20 p.p.m.

Ascorbic acid (Max) 200 p.p.m.

Page 153: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

562 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Fortified Maida means the product obtained by adding one or more of the following materials to maida,namely:—

(a) Calcium carbonate (preparated chalk popularly known as creta preparata)

(b) Iron,

(c) Thiamine,

(d) Riboflavin, and

(e) Niacin.

The calcium carbonate powder, if added for fortification, shall be in such amount that 100 parts by weight offortified maida shall contain not less than 0.30 and not more than 0.35 parts by weight of calcium carbonate. It shallbe free from Rodent hair and excreta.

(3) Protein Rich (Paushtik) Maida means the product obtained by mixing maida (wheat flour) with groundnutflour “or Soya flour; or a combination of both” up to an extent of 10.0 per cent Soya flour which is a solvent extractedflour used in such mix shall conform to the standards of soya flour laid down under Regulation 5.4.13 (1) It shall befree from insect or fungus infestation, odour and rancid taste. It shall not contain added flavour and colouringagents or any other extraneous matter. It shall conform to the following standards:

Moisture Not more than 14.0 per cent

Total ash Not more than 1.4 per cent on dry basis.

Ash insoluble in dilute HCl Not more than 0.1 percent on dry basis.

Total Protein (N x 6.25) Not less than 12.5 percent on dry basis

Crude Fibre Not more than 0.53 per cent on dry basis

Alcoholic acidity (with 90 per cent alcohol) expressed Not more than 0.12 per centas H2SO4

Gluten Not less than 7.0 percent on dry basis

It shall be free from Rodent hair and excreta

Regulation 5.4.3 Semolina (Suji or Rawa):

(1) Semolina (Suji or Rawa) means the product prepared from clean wheat free from rodent hair and excreta byprocess of grinding and bolting. It shall be free from musty smell and off-odour and shall be creamy yellow in colour.It shall conform to the following standards:—

Moisture Not more than 14.5 per cent (when determined byheating at 130-133oC for 2 hours).

Total ash Not more than 1.0 per cent (on dry weight basis).

Ash insoluble in dilute HCl Not more than 0.1 percent (on dry weight basis).

Gluten (on dry weight basis). Not less than 6.0 per cent

Alcoholic acidity (with 90 per cent alcohol) expressed Not more than 0.18 per centas H2SO4 (on dry weight basis)

It shall be free from Rodent hair and excreta

Regulation 5.4.4 Besan:

(1) Besan means the product obtained by grinding dehusked Bengal gram (Cicer arietinum) and shall notcontain any added colouring matter or any other foreign ingredient.

Besan shall conform to the following standards:—

Page 154: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 563

Total ash Not more than 5.0%.

Ash insoluble in dilute hydrochloric acid Not more than 0.5%.

Regulation 5.4.5 Pearl Barley (Jau)

(1) Pearl Barley (Jau) shall be the product obtained from sound and clean barley (Horbeum vulgare orhordeum distichon) It shall be whitish in colour and shall be free from fermented, musty or other objectionable tasteor odour, adulterants and insect and fungus infestation and rodent contamination. It shall not contain other foodgrainsmore than 1 per cent by weight.

Barley powder shall be the product obtained by grinding clean and sound dehusked barley (Hordeum vulgareor Hordeum distichon) grains. Barley starches shall not be less than 98.0 per cent by weight.

Barley powder shall also conform to the following standards namely:—

Total ash (on dry basis) Not more than 1.0%.

Ash insoluble in dilutehydrochloric acid (on dry basis) Not more than 0.1%.

Crude fibre (on dry basis) Not more than 0.5%.

Alcoholic acidity (as H2SO4)with 90 per cent alcohol) Not more than 0.10 per cent.

(2) Wholemeal Barley Powder Or Barley Flour Or Choker Yukt Jau ka Churan means the product obtained bygrinding clean and sound dehusked barley (Hordeum vulgare or Hordeum distichun) grains free from rodent hair andexcreta]. It shall conform to the following standards:—

Moisture Not more than 14.0 per cent

(when determined by heating at 130-133oC for 2hours).

Total ash Not more than 3.0 per cent (on dry weight basis).

Ash insoluble in dilute HCl Not more than 0.5 percent (on dry weight basis).

Alcoholic acidity (with 90 per cent alcohol) Not more than 0.17 per centexpressed as H2SO4 (on dry weight basis)

Regulation 5.4.6 Food grains:

(1) Food grains meant for human consumption shall be whole or broken kernels of cereals, millets and pulses.In addition to the undermentioned standards to which foodgrains shall conform, they shall be free from Argemone,Maxicana and Kesari in any form. They shall be free from added colouring matter. The foodgrains shall not containany insecticide residues other than those specified in Regulation 8.3.1 and the amount of insecticide residue in thefoodgrains shall not exceed the limits specified in Regulation 8.3.1 of the said Table. The foodgrains meant forgrinding/processing shall be clean, free from all impurities including foreign matter (extraneous matter).

(2) Wheat

Description: Wheat shall be the dried mature grains of Triticum aestivum Linn. or Triticum vulgare vill, triticumdrum Desf., triticum sphaerococcum perc., Triticum dicoccum schubl., Triticum Compactum Host. It shall be sweet,clean and wholesome. It shall also conform to the following standards namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverised grains at 130oC-133oC fortwo hours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which notmore than

Page 155: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

564 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(Extraneous matter) 0.25 per cent. By weight shall be mineral matter andnot more than 0.10 per cent. by weight shall beimpurities of animal origin.

(iii) Other edible grains Not more than 6 per cent by weight.

(iv) Damaged grains- Not more than 6.0 per cent by weight including kernelbunt afected grains and got affected grains. Thelimit of kernel bunt affected grains and ergot affectedgrains shall not exceed 3.0 per cent and 0.05 percentby weight, respectively.

(v) Weevilled grains- Not more than 10 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram

(viii) Deoxynivalenol(DON) Not more than 1000 micrograms per kilogram

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 12 per centby weight.

(3) Maize:

Maize shall be the dried mature grains of Zea mays Linn. It shall be sweet, hard, clean and wholesome. It shallalso conform to the following standards, namely:—

(i) Moisture- Not more than 16.0 per cent by weight (obtained byheating the pulverised grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which notmore than

(Extraneous matter) 0.25 per cent. by weight shall be mineral matter andnot more than 0.10 per cent. by weight shall beimpurities of animal origin.

(iii) Other edible grains - Not more than 3 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 10 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 9 per cent byweight.

(4) Jawar And Bajra:

Jawar and Bajra shall be the dried mature grains of Sorghum Vulgare Pers. and

Pennisetum - typhyoideum Rich, respectively. These shall be sweet, hard, clean and wholesome. These shallalso conform to the following standards, namely:—

(i) Moisture- Not more than 16.0 per cent by weight (obtained byheating the pulverised grains at 130oC-133oC for twohours).

(ii) Foreign matter -Extraneous Matter Not more than 1 per cent. by weight of which notmore than 0.25 per cent. by weight shall be mineralmatter and not more than 0.10 per cent by weightshall be impurities of animal origin.

Page 156: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 565

(iii) Other edible grains Not more than 3 per cent by weight.

(iv) Damaged grains Not more than 6 per cent by weight.

(v) Weevilled grains Not more than 10 per cent by count.

(vi) Uric acid Not more than 100 mg per kg

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 10 per centby weight.

(5) Rice:

Rice shall be the mature kernels or pieces of kernels of Oryza sativa Linn. obtained from paddy as raw or parboiled. It shall be dry, sweet, clean, wholesome and free from unwholesome poisonous substance. It shall alsoconform to the following standards, namely:—

(i) Moisture- Not more than 16 per cent by weight (obtained byheating the pulverised grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than0.25 per cent. By weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Damaged grains- Not more than 5 per cent by weight

(iv) Weevilled grains- Not more than 10 per cent by count.

(v) Uric acid- Not more than 100 mg. per kg.

(vi) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, and damaged grains shall not exceed 6 per cent by weight.

(6) Masur Whole:

Masur whole shall consist of lentil (lens culinaris Medik or Even lens Linn. or Lens esculenta Moench) It shallbe sound, dry, sweet, clean and wholesome. It shall conform to the following standards, namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC 133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin

(iii) Other edible grains- Not more than 3 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 6 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 8 per cent byweight.

Page 157: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

566 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(7) Urd Whole:

Urd whole shall consist of seeds of the pulses (phaseolus mungo Linn) It shall be sound, dry, sweet andwholesome. It shall also conform to the following standards, namely:—

(i) Moisture- Not more than 14.0 per cent by weight (obtained byheating the pulverised grains at 130oC-133oC for twohours).

(ii) Foreign matter -Extraneous Matter Not more than 1 per cent. by weight of which notmore than 0.25 per cent. by weight shall be mineralmatter and not more than 0.10 per cent by weightshall be impurities of animal origin.

(iii) Other edible grains Not more than 4 per cent by weight.(iv) Damaged grains Not more than 5 per cent by weight.(v) Weevilled grains Not more than 6 per cent by count.(vi) Uric acid Not more than 100 mg per kg(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 9 per cent byweight.

(8) Moong Whole:

Moong whole shall consist of seeds of green gram (Phaseolous aurues Roxb., Phaseolus radiatus Roxb.) Itshall be sound, dry, sweet, wholesome and free from admixture of unwholesome substances. It shall also conform tothe following standards, namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Other edible grains - Not more than 4 per cent by weight.(iv) Damaged grains- Not more than 5 per cent by weight.(v) Weevilled grains- Not more than 6 per cent by count.(vi) Uric acid- Not more than 100 mg. per kg.(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 9 per cent byweight.

(9) Chana Whole:

Channa whole shall be the dried grains of gram (cicer arietinum Linn.) It shall be sound, clean, sweet, wholesomeand free from unwholesome substances. It shall also conform to the following standards, namely:—

(i) Moisture- Not more than 16 per cent by wight (obtained byheating the pulverised grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

Page 158: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 567

(iii) Other edible grains - Not more than 4 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 10 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 9 per cent byweight.

(10) Split Pulse (Dal) Arhar:

Dal Arhar shall consist of husk and split seeds of red gram (Cajanus cajan (L) Millsp) It shall be sound, clean,sweet, dry, wholesome and free from admixture of unwholesome substance. It shall also conform to the followingstandards, namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Other edible grains - Not more than 0.5 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 3 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 6 per cent byweight.

(11) Plit Pulse (Dal) Moong:

Dal Moong shall consist of split seeds of green grams (Phaseolus aureus Roxb, Phaseolus raditus) It shall besound, clean, sweet, wholesome and free from unwholesome. It shall also conform to the following standards,namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. By weightshall be impurities of animal origin.

(iii) Other edible grains - Not more than 4 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 3 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Page 159: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

568 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 8 per cent byweight.

(12) Split Pulse (Dal) Urd:

Dal Urd shall consist of split seeds of pulse (Phaseolus mungo Linn.) It shall be sound, dry, sweet, wholesomeand free from admixture of unwholesome substances. It shall also conform to the following standards, namely:—

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Other edible grains - Not more than 4 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 3 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 8 per cent byweight.

(13) Dal Chana:

Dal Chana shall consist of split grains of gram (Cicer arietinum Linn) It shall be sound, clean, sweet, dry,wholesome and free from admixture of unwholesome substances. It shall also conform to the following standards,namely:—

(i) Moisture- Not more than 16 per cent by weight(obtained byheating the pulverizedgrains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weightof which not(Extraneous matter) more than 0.25 per cent.by weight shall be mineral

matter andnot more than 0.10 per cent. by weightshallbe impurities of animal origin.

(iii) Other edible grains Not more than 2 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 3 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 7 per cent byweight.

(14) Split Pulse Masur:

Dal masur shall consist of dehusked whole and split seed of the lentil (Lenil esculenta Moench or Lensculinaris Medik or Ervem lens Linn) It shall be sound, clean, dry, sweet, wholesome and free from admixture ofunwholesome substances. It shall also conform to the following standards, namely:—

Page 160: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 569

(i) Moisture- Not more than 14 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Other edible grains - Not more than 2 per cent by weight.

(iv) Damaged grains- Not more than 5 per cent by weight.

(v) Weevilled grains- Not more than 3 per cent by count.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that the total of foreign matter, other edible grains and damaged grains shall not exceed 7 per cent byweight.

(15) Any other foodgrains not specified above shall conform to the following standards, namely:—

(i) Moisture- Not more than 16 per cent by weight (obtained byheating the pulverized grains at 130oC-133oC for twohours).

(ii) Foreign matter - Not more than 1 per cent. by weight of which not(Extraneous matter) more than 0.25 per cent. by weight shall be mineral

matter and not more than 0.10 per cent. by weightshall be impurities of animal origin.

(iii) Other edible grains Not more than 6 per cent by weight.

(iv) Weevilled grains- Not more than 10 per cent by count.

(v) Damaged grains- Not more than 5 per cent by weight.

(vi) Uric acid- Not more than 100 mg. per kg.

(vii) Aflatoxin Not more than 30 micrograms per kilogram.

Provided that total of foreign matter, other edible grains and damaged grains shall not exceed 12.0 per cent byweight.

Explanation - For the purposes of items in Regulation 5.4.6 (2-14):—

(a) “foreign matter” means any extraneous matter other than foodgrains comprising of—

(i) inorganic matter consisting or metallic pieces, sand, gravel, dirt, pebbles, stones, lumps ofearth, clay and mud, animal filth and in the case of rice, kernels or pieces of kernels, if any, havingmudsticking on the surface of the rice, and

(ii) organic matter consisting of husk, straws, weed seeds and other inedible grains and alsopaddy in the case of rice;

(b) poisonous, toxic and/or harmful seeds - means any seeds which is present in quantities abovepermissible limit may have damaging or dangerous effect on health, organoleptic properties or technologicalperformance such as dhatura (D. fastur linn and D. stramonium linn), corn cokle (Agrostemma githago L,Machai Lallium remulenum linn), Akra (Vicia species)

(c) “Damaged grains” means kernels or pieces of kernels that are sprouted or internally damaged as aresult of heat, microbe, moisture or whether, viz., ergot affected grain and kernel bunt grains;

Page 161: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

570 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(d) “Weevilled grains” means kernels that are partially or wholly bored by insects injurious to grains butdoes not include germ eaten grains and egg spotted grains;

(e) “Other edible grains” means any edible grains (including oil seeds) other than the one which is underconsideration.

Regulation 5.4.7 Cornflour (Maize starch):

(1) Cornflour (Maize starch) means the starch obtained from maize (zea mays L.) It shall contain no addedcolour, flavours or other chemicals. It shall be free from dirt, insects, larvae and impurities or other extraneous matter.It shall conform to the following standards:—

Moisture Not more than 12.5%

Total ash Not more than 0.5 per cent(on dry weight basis).

Ash insoluble in dilute HCl Not more than 0.1 percent (on dry weight basis).

Alcoholic acidity (with 90 per cent alcohol) Shall be equivalent to not more than 2.0 ml. N.NaOH per 100 g. of dried starch

Regulation 5.4.8. Corn Flakes:

(1) Corn Flakes means the product obtained from dehulled, degermed and cook corn (Zea mays L.) by flaking,partially drying and toasting. It shall be in the form of crisp flakes of reasonably uniform size and golden brown incolour. It shall be free from dirt, insects, larvae and impurities and any other extraneous matter. It shall conform to thefollowing standards:—

Moisture Not more than 7.5%

Total ash excluding salt Not more than 1.0 per cent(on dry weight basis).

Ash insoluble in dilute HCl Not more than 0.1 percent (on dry weight basis).

Alcoholic acidity (with 90 per cent alcohol) Shall be equivalent to not more than 2.0 ml. N.NaOH per 100 g. of dried starch

Regulation 5.4.9 Custard Powder:

(1) Custard Powder means the product obtained from maize (Zea mays L.) or sago/topioca with or without theaddition of small quantities of edible starches obtained from arrowroot, potato or jawar (sorghum vulgare) and withor without the addition of edible common salt, milk and albuminous matter. It may contain permitted colours andflavours. It shall be free from any other foreign matter. It shall be the form of fine powder, free from rancidity,fermented and musty odour. It shall conform to the following standards namely:—

Moisture Not more than 12.5%

Total ash excluding added common salt (on dry basis) Not more than 0.5 per cent

Ash insoluble in dilute HCl (on dry basis). Not more than 0.1 percent

Regulation 5.4.10 Macaroni Products:

(1) Macaroni Products-(Macaroni, spaghetti, vermicelli) means the products obtained from suji or maidawith or without addition of ingredients like edible groundnut flour, tapioca flour, soya flour, milk powder, spices,vitamins, minerals, by kneading the dough and extending it. It shall be free from added colour, dirt, insects larvae andimpurities or any other extraneous matter. It shall conform to the following standards:—

Moisture Not more than 12.5%

Total ash Not more than 1.0 per cent on dry basis

Ash insoluble in dilute HCl (on dry basis). Not more than 0.1 percent

Nitrogen Not less than 1.7 per cent on dry basis

Page 162: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 571

Regulation 5.4.11 Malted & Malt Based Foods

(1) Malted Milk Food means the product obtained by mixing whole milk, partly skimmed milk or milk powderwith the wort separately from a mash of ground barley malt, any other malted cereal grain and wheat flour or anyother cereal flour or malt extract with or without addition of flavouring agents and spices, emulsifying agents, eggs,protein isolates, edible common salt, sodium or potassium bicarbonate, minerals and vitamins and without addedsugar in such a manner as to secure complete hydrolysis of starchy material and prepared in a powder or granule orflake form by roller drying, spray drying, vacuum drying or by any other process. It may contain cocoa powder. Itshall be free from dirt and other extraneous matter. It shall not contain any added starch (except starch natural tococoa powder) and added non-milk fat. It shall not contain any preservative or added colour. Malted milk foodcontaining cocoa powder may contain added sugar. Malted milk food shall also conform to the following standards,namely:—

Malted milkfood without Malted milkfood withcocoa powderCocoa powder

(a) Moisture Not more than 5 per cent by weight. Not more than 5per cent by weight(b) Total protein(N x 6.25) Not less than 12.5 per cent by weight. Not less than 11.25per cent by weight.

(on dry basis)(c) Total fat (onDry basis) Not less than 7.5%by weight Not less than 6%by weight.(d) Total ash (ondry basis) Not more than 5% by weight Not more than 5% by weight.(e) Acid insolubleash Not more than 0.1 per cent by weight Not more than 0.1 per cent by weight

(on dry basis)(in dilute HCl)

(f) Solubility Not less than 85% by weight. Not less than 80% by weight.(g) Cocoa powder(on dry basis) — Not less than 5.0% by weight.(h) Test for starch Negative —(i) Bacterial count Not more than50,000 per gram. Not more than50,000 per gram.(j) Coliform count Not more than10 per gram. Not more than 10 per gram.(k) Yeast and mould count absent in 0.1 gm(l) Salmonella and Shigella absent in 0.1 gm(m) E.Coli absent in 0.1 gm(n) Vibrio cholera and absent in 0.1 gm

V.Paraheamolyticus(o) Faecal streptococci and absent in 0.1 gm

Staphylococcus aureas

(2) Malt Based Foods (Malt Food) means the product obtained by mixing malt (wort or flour or malt extract) ofany kind obtained by controlled germination of seeds (cereals and/or grain legumes), involving mainly steepinggermination and kiln drying processes with other cereal and legume flour with or without whole milk or milk powder,flavouring agents, spices, emulsifying agents, eggs, egg powder, protein isolates, protein hydrolysates, ediblecommon salt, liquid glucose, sodium or potassium bicarbonate minerals, amino acids and vitamins. It may containadded sugar and/or cocoa powder and processed in such a manner to secure partial or complete hydrolysis ofstarchy material in the form of powder or granules or flakes by drying or by dry mixing of the ingredients. The grains,legumes and their products used in preparation of malt shall be sound, uninfested and free from insect fragments, ratexcreta, fungal infested grains or any other type of insect or fungal damage.

It shall also conform to the following standards, namely:—

(a) Moisture - Not more than 5 per cent, by weight

(b) Total Protein (N x 6.25)(on dry basis) - Not less than 7.0 per cent, by weight

(c) Total ash (on dry basis) - Not more than 5 per cent, by weight

(d) Acid insoluble ash(in dilute HCl) - Not more than 0.1 per cent, by weight

Page 163: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

572 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(e) Total plate count - Not more than 50,000 per gram.

(f) Coliform count - Not more than 10 per gram.

(g) Yeast and Mould Count - Not more than 100 per gram.

(h) E Coli - Absent in 10 gram.

(i) Salmonella and Shingella - Absent in 25 gram

(j) Alcoholic Acidity(expressed as H2SO4) - Not more than 0.30 per cent.with 90 per cent alcohol (on dry weight basis)

(k) Vibrio cholera and V.Paraheamolyticus absent in 0.1 gm

(l). Faecal streptococci and Staphylococcus aureas absent in 0.1 gm

Regulation 5.4.12 Rolled Oats:

(1) Rolled Oats (quick cooking oats) means the product made from sound hulled oats (Avena sativa). It shallbe free from added colours, rancidity and flavouring agents. It shall be in the form of flakes of uniform size havinga light cream colour. It shall be free from dirt, insects and insect fragments. It shall conform to the followingstandards:—

Moisture Not more than 10.0 %

Total ash Not more than 2.0 per cent on dry basis

Ash insoluble in dilute HCl (on dry basis). Not more than 0.1 percent

Nitrogen Not less than 1.8 per cent on dry basis

Crude Fibre Not more than 2.0 percent on dry basis

Alcohol acidity (with 90 per cent alcohol) Shall be equivalent to not more than 8.0 ml.N.NaOH per 100 gm. of dried substance.

Regulation 5.4.13 Solvent Extracted Flours:

(1) Solvent Extract Soya Flour means the product obtained from clean, sound healthy soyabeans by aprocess of cracking, dehulling, solvent extraction with food grade hexane and grinding. It shall be in the form ofcoarse or fine powder or grits, white to creamy white in colour of uniform composition and free from rancid andobjectionable odour, extraneous matter, insects, fungus, rodent hair and excreta. It shall be free from any addedcolour and flavour. It shall conform to the following standards, namely:—

(a) Moisture Not more than 9.0 per cent by weight

(b) Total ash Not more than 7.2 per cent by weight on dry basis

(c) Ash insoluble in dilute HCl Not more than 0.4 per cent by weight on dry basis.

(d) Protein (Nx6.25) Not less than 48 per cent by weight on dry basis.

(e) Crude fibre Not more than 4.2 per cent by weight on dry basis.

(f) Fat Not more than 1.5 per cent by weight on dry basis

(g) Total bacterial count Not more than 50,000 per gm.

(h) Coliform bacteria Not more than 10 per gm.

(i) Salmonella bacteria Nil in 25 gm

(j) Hexane (Food grade) Not more than 10.00 ppm

(2) Solvent Extracted Groundnut Flour means the product obtained from fresh, clean, degermed groundnutkernels which have been decuticled after mild roasting. The kernels shall be first expelled followed by solventextraction with food grade hexane or by direct extraction of kernels. It shall be whitish to light brown in colour ofuniform composition and shall be free from rancid and objectionable odour, extraneous matter, insect, fungus,

Page 164: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 573

rodent hair and excreta. It shall be free from added colour and flavour. It shall conform to the following standardsnamely :—

(a) Moisture Not more than 8.0 per cent by weight

(b) Total ash Not more than 5.0 per cent by weight on dry basis

(c) Ash insoluble in dilute HCl Not more than 0.38 per cent by weight on drybasis.

(d) Protein (Nx6.25) Not less than 48 per cent by weight on dry basis.

(e) Crude fibre Not more than 5.0 per cent by weight on dry basis.

(f) Fat Not more than 1.5 per cent by weight on dry basis

(g) Total bacterial Not more than 50,000 per gm.count

(h) Coliform bacteria Not more than 10 per gm.

(i) Salmonella bacteria Nil in 25 gm

(j) Hexane (Food grade) Not more than 10.00 ppm

(3) Solvent Extracted Sesame Flour means the product obtained by pressing, clean, sound healthy anddecuticled sesame seeds followed by solvent extraction with food grade hexane or by direct extraction of kernels. Itshall be in the form of flour of white or pale creamy white colour, of uniform composition and free from rancid andobjectionable odour, extraneous matter, insects, fungus, rodent hair and excreta. It shall be free from added colourand flavour. It shall conform to the following standards, namely :—

(a) Moisture Not more than 9.0 per cent by Weight

(b) Total ash Not more than 6.0 per cent by weight on dry basis

(c) Ash insoluble in dilute HCl Not more than 0.15 per cent by weight on dry basis.

(d) Protein (Nx6.25) Not less than 47 per cent by weight on dry basis.

(e) Crude fibre Not more than 6.0 per cent by weight on dry basis.

(f) Fat Not more than 1.5 per cent by weight on dry basis

(g) Total bacterial count Not more than 50,000 per gm.

(h) Coliform bacteria Not more than 10 per gm.

(i) Salmonella bacteria Nil in 25 gm.

(j) Oxalic Acid Not more than 0.5 per cent by weight content on drybasis.

(k) Hexane (Food grade) Not more than 10.00 ppm.

(4) Solvent Extracted Coconut Flour means the product obtained from fresh coconut Kernels or dried coconutcopra of good quality and free from mould. Food grade hexane shall be used for extraction of the oil. It shall be ofwhite or pale brownish yellow colour of uniform composition and free from rancid and objectionable odour, extraneousmatter, insects, fungus, rodent hair and excreta. It shall be free from added colour and flavour. It shall conform to thefollowing standards, namely :—

(a) Moisture Not more than 9.0 per cent by weight

(b) Total ash Not more than 6.0 per cent by weight on dry basis

(c) Ash insoluble in - dilute HCl Not more than 0.35 per cent by weight on dry basis.

(d) Protein (Nx6.25) Not less than 22.0 per cent by weight on dry basis.

(e) Crude fibre Not more than 9.0 per cent by weight on dry basis.

(f) Fat Not more than 1.5 per cent by weight on dry basis

Page 165: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

574 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(g) Total bacterial - Not more than 50,000 per gm.count

(h) Coliform bacteria Not more than 10 per gm.

(i) Salmonella bacteria Nil in 25 gm.

(j) Hexane (Food grade) Not more than 10.00 ppm.

(5) Solvent Extracted Cotton Seed Flour means the product obtained by solvent extraction of oil with foodgrade hexane from oil cake immediately following the single pressing, from cotton seed of good quality which havebeen pre-cleaned and are free from infected or otherwise damage materials and extraneous matter. It shall be in theform of flour of white or pale brownish colour, of uniform composition and free from rancid and objectionable odour,extraneous matter, insect, fungus, rodent hair and excreta. It shall be free from added colours and flavours. It shallconform to the following standards, namely :—

(a) Moisture Not more than 8.0 per cent by weight

(b) Total ash Not more than 5.0 per cent by weight on dry basis

(c) Ash insoluble in dilute HCl Not more than 0.35 per cent by weight on dry basis.

(d) Crude Protein (Nx6.25) Not less than 47 per cent by weight on dry basis.

(e) Available lysine Not less than 3.6 g. per 100 g. of crude protein.

(f) Crude fibre Not more than 5.0 per cent by weight on dry basis.

(g) Free gossypol Not more than 0.06 per cent by weight on dry basis.

(h) Total gossypol Not more than 1.2 percent by weight on dry basis.

(i) Fat Not more than 1.5 per cent by weight on dry basis.

(j) Total bacterial Count Not more than 50,000 per gm.

(k) Coliform bacteria Not more than 10 per gm.

(l) Salmonella bacteria Nil in 25 gm.

(m) Hexane (Food grade) - Not more than 10.00 ppm.”

Regulation 5.4.14 Starchy Foods:

(1) Arrowroot means the separated and purified starch from the rhizomes of the plants known as Marantaarundinacea or from Curcuma augustifolia.

(2) Sago shall mean small hard globules or pearls made from either the starch of the sago palm or the tubers oftopioca (Manihot utilissima) and shall be free from any extraneous matter including natural colours.

It shall conform to the following standards, namely:—

(i) total ash (on dry basis) shall not be more than 0.4 percent;

(ii) ash insoluble in dilute hydrochloric acid (on dry basis). shall not exceed 0.1 percent

Regulation 5.4.15 Bakery Products:

(1) Biscuits including wafer biscuits shall be made from maida, vanaspati or refined edible oil or table butteror desi butter or margarine or ghee or their mixture containing any one or more of the following ingredients,namely:—

Edible common salt, butter, milk powder, cereals and their products, cheese cocoa, coffee extract, edibledesiccated coconut, dextrose, fruit and fruits products, dry fruit and nuts, egg, edible vegetable products, ginger,gluten groundnut flour, milk and milk products, honey, liquid glucose, malt products, edible oilseeds, flour andmeals, spices and condiments, edible starches such as potato starch and edible flours, sugar and sugar products,invert sugar, jaggery, protein concentrates, oligofructose (max 15%) vinegar and other nutrients and vitamins:

Provided that it may contain food additives specified in these regulations and in Appendix A:

Page 166: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 575

Provided further that it may contain artificial sweetener as provided in Regulation 6.1.2 and label declarationas provided in Regulation 4.4.5 (24, 25, 26, 28 & 29)

Provided also that it shall conform to following standards, namely:—

(i) ash insoluble in dilute hydrochloric acid (on dry basis): shall not be more than 0.1 per cent

(ii) acidity of extracted fat (as oleic acid):- not exceeding 1.5 per cent.

It may contain Oligofructose (dietary fibres) upto 15% maximum subject to label declaration under Regulation4.4.5 (43)

(2) Bread whether sold as white bread or wheat bread or fancy or fruity bread or bun or masala bread or milkbread or of any other name, shall mean the product prepared from a mixture of wheat atta, maida, water, salt, yeast orother fermentive medium containing one or more of the following ingredients, namely:—

Condensed milk, milk powder (whole or skimmed), whey, curd, gluten, sugar, gur or jaggery, khandsari, honey,liquid glucose, malt products, edible starches and flour, edible groundnut flour, edible soya flour, protein concentratesand isolates, vanaspati, margarine or refined edible oil of suitable type or butter or ghee or their mixture, albumin,lime water, lysine, vitamins, spices and condiments or their extracts, fruit and fruit product (Candied and crystallizedor glazed), nuts, nut products , oligofructose (max 15%) and vinegar:

Provided that it may also contain food additives specified in these regulations including Appendix A:

Provided further that it may also contain artificial sweetener as provided under label declaration in Regulation4.4.5 (24, 25, 26, 28 & 29) ;

Provided also that it shall conform to the following standards, namely:—

(a) alcoholic acidity (with 90 per cent alcohol) Shall be not more than equivalent of 7.5 ml.N NaOH per 100 g of dried substances.

(b) ash insoluble in dilute HCL on dry weight basis —

(i) bread except masala bread or fruit bread Not more than 0.1 per cent

(ii) masala bread or fruit bread Not more than 0.2 per cent

Provided also that it shall be free from dirt, insect and insect fragments, larvae, rodent hairs and addedcolouring matter except any permitted food colours present as a carry over colour in accordance with the provisionin Regulation 6.1.17, in raw material used in the products.

It may contain Oligofructose (dietary fibres) upto 15% maximum subject to label declaration under labellingRegulation 4.4.5 (43)

PART 5.5. Meat and Meat Products

Regulation 5.5.1 Definition:

(a) “animal” means an animal belonging to any of the species specified below;—

(i) Ovines;

(ii) Caprines;

(iii) Suillines;

(iv) Bovines;

and includes poultry and fish

(b) “carcass” means the dead body or any part thereof including the viscera of any animal which has beenslaughtered

(c) “meat” means the flesh and other edible parts of a carcass

(d) “meat food products” means any article of food or any article intended for, or capable of, being used as afood which is derived or prepared from meat by means of drying, curing, smoking, cooking, seasoning, flavouring,

Page 167: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

576 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

freezing or following a method of processing meat akin to any of the above methods, but shall not include thefollowing products unless the manufacturer himself desires to be covered under the provisions of the said Regulations,namely:—

(i) Meat extracts, meat consommé and stock, meat sauces and similar products not containing fragmentsof meat;

(ii) Whole, broken or crushed bones, meat peptones, animal gelatin, meat powder, pork-rind powder,blood plasma, dried blood, dried blood plasma, cellular proteins, bone extracts and similar products;

(iii) Fats melted down from animal tissues;(iv) Stomachs, bladders and intestines, clean and bleached, salted or dried;(v) Products containing fragments of meat, but which contain a quantity of meat or meat product not

exceeding ten percent of the total weight of the final product;(vi) Patties, puffs, rolls, samosas, cutlets, koftas, kababs, chops, tikkas and soups made from mutton,

chicken, goat meat, buffalo meat, beef and grilled chicken which are prepared for immediate consumption, theampoules of chicken essence, hot-dogs and hamburgers prepared for immediate consumption which can notbe stored even under refrigerated conditions; * 2

(vii) Chilled Poultry

(e) “Slaughter house” means the building, premises or place which is licensed as a slaughter house by thelocal authority for the slaughter of animals intended for human consumption.

Regulation 5.5.2 Meat and Meat Products:

(1) Corned Beef means the product prepared from boneless meat of carcass of bovine animals includingbuffalo meat, which have been subjected to antimortem and postmortem inspection.

The product shall be uniformly cured with edible common salt and sodium and / or potassium nitrite. Theproduct may contain ascorbic acid, sodium ascorbate or isoascorbate acid/ sodium iso-ascorbate singly or incombination not exceeding 500 mg/kg. The product may also contain sucrose, dextrose, lactose, maltose andglucose syrup including corn syrup.

The product shall be packed in hermetically sealed containers and subjected to heat treatment followed byrapid cooling to ensure that the product is shelf stable. The sealed containers shall not show any change onincubation at 35oC for 10 days and 55oC for 5 days.

The product shall be in the form of a solid pack capable of being sliced.

The product shall be free from any added colour and natural and artificial flavour. The product shall be cleanand substantially free from staining and contamination from the container, foreign matter and objectionable odour.

The product shall conform to the following requirements, namely:—

Sl. No. Characteristics Requirements

(1) Total Plate Count 1000 / gram maximum(2) E.Coli Absent in 25 gram(3) Solmonella Absent in 25 gram(4) Staphylococcus aureus Absent in 25 gram(5) Clostridium perfringens andClostridium Botulinum Absent in 25 gram

(2) Luncheon Meat means the product prepared from edible portion of meat of mammalian animal, slaughteredin an abattoir, which have been subjected to antimortem and postmortem inspection and/or edible meat of poultry,birds, including chickens, turkeys, ducks, geese, guinea fowl or pigeons slaughtered in an abattoir.

The product shall be uniformly cured with edible common salt and sodium and /or potassium nitrite. Theproduct may be with or without binders such as cereal flour/starch, bread, biscuits or bakery products, milk powder,whey powder, egg protein, vegetable protein products, glucose, invert sugar, dextrose, lactose, maltose, glucosesyrup, including corn syrup, spices, seasoning and condiments and water soluble hydrolysed protein.

Page 168: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 577

The product may be smoked and flavoured with natural and natural identical flavours and permitted flavourenhancer.

The product may contain ascorbic acid / isoascorbic acid and its sodium salts singly or in combination notexceeding 500 mg/kg expressed as ascorbic acid as antioxidant and sodium and or potassium mono - di -polyphosphates singly or in combination not exceeding 3000 mg/kg expressed as P2O5 as water retention agents.

The product shall be packed in hermetically sealed container and subjected to heat treatment followed byrapid cooling to ensure that the product is shelf stable. The sealed container shall not show any change onincubation at 35oC for 10 days and 55oC for 5 days.

The product shall be clean and substantially free from stains from the container and foreign matter and shallbe capable of being sliced.

The product shall conform to the following requirement, namely:—

Sl. No. Characteristics Requirements

(1) Total Fat content:a) Product without binder Not more than 30.0 percentb) Product with binder Not more than 35.0 percent

(2) Total Plate Count 1000 / gram maximum(3) E.Coli Absent in 25 gram(4) Salmonella Absent in 25 gram(5) Staphylococcus aureus Absent in 25 gram(6) Clostridium perfringens andClostridium Botulinum Absent in 25 gram

(3) Cooked Ham means the product prepared from meat of pigs which have been subjected to antimortem andpostmortem inspection. The product shall be free from bones, detached cartilage tendous, ligaments and may bewith or without skin and fat. The product shall be uniformly cured with edible common salt and sodium and / orpotassium nitrite.

The product may contain sucrose, invert sugar, dextrose, lactose, maltose, glucose syrup including cornsyrup, honey, spices, seasoning and condiments, water soluble hydrolysed protein and food grade gelatin. Theproduct may be smoked and flavoured with natural flavouring substances and nature identical flavours as well aspermitted flavour enhancers. The product may contain ascorbic acid / isoascorbic acid and its sodium salt singly orin combination not exceeding 500 mg/kg expressed as ascorbic acid, sodium and or potassium mono - di -polyphosphates singly or in combination not exceeding 3000 mg/ kg expressed as P2O5 as antioxidant and waterretention agents respectively. The product may also contain sodium/potassium alginate not exceeding 10 mg/kgand or agar, carrageenan and sodium citrate as emulsifying and stabilizing agents.

The product shall be packed in hermetically sealed containers and subjected to heat treatment followed byrapid cooling to ensure that the product is shelf stable. The sealed containers shall not show any change onincubation at 350C for 10 days and 550C for 5 days.

The product shall be free from any stains from the container/package, objectionable matter and shall becapable of being sliced.

The product shall confirm to the following requirement, namely:—

Sl. No. Characteristics Requirements

(1) Total Plate Count 1000 / gram maximum(2) E.Coli Absent in 25 gram(3) Salmonella Absent in 25 gram(4) Staphylococcus aureus Absent in 25 gram(5) Clostridium perfringens andClostridium Botulinum Absent in 25 gram

Page 169: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

578 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(4) CHOPPED MEAT means the product prepared form edible portion of meat of mammalian animals slaughteredin an abattoir, which have been subjected to antimortem and postmortem inspection and / or edible meat of poultrybirds including chickens, turkeys, ducks, geese, slaughtered in an abattoir.

The product shall be uniformly cured with edible common salt and Sodium or Potassium Nitrite. The productmay be with or without binders such as cereal flour/starch, bread, biscuit, or bakery product. Vegetable proteinproduct, fructose, invert sugar; dextrose, lactose, maltose, glucose syrup including corn syrup, spices, seasoningand condiments and water soluble hydrolysed protein.

The product may be smoked and flavoured with natural and nature identical flavours and permitted flavourenhancer.

The product may contain ascorbic acid / iso-ascorbic acid and its sodium salts singly or in combination notexceeding 500 mg / kg expressed as ascorbic acid and sodium and or potassium mono-di-polyphosphate, singly orin combination not exceeding 3000 mg/kg expressed as P205 as antioxidants and water retention agent respectively.

The product shall be packed in hermetically sealed containers and subjected to heat treatment followed byrapid cooling to ensure that the product is shelf stable. The sealed containers shall not show any change onincubation at 35oC for 10 days and 55oC for 5 days.

The product shall be clean and substantially free from staining and contamination from the container, foreignmatter and shall be capable of being sliced.The product shall conform to the following requirements, namely:—

Sl. No. Characteristics Requirements

(1) Total Fat content:a) Product without binder Not more than 25.0 percentb) Product with binder Not more than 30.0 percent

(2) Total Plate Count 1000 / gram maximum(3) E.Coli Absent in 25 gram(4) Salmonella Absent in 25 gram(5) Staphylococcus aureus Absent in 25 gram(6) Clostridium perfringens and Clostridium Botulinum Absent in 25 gram

(5) Canned Chicken means the product prepared from edible portion of meat of poultry birds, slaughtered inan abattoir, which have been subjected to antimortem and postmortem inspection. The product shall be free frombones, blood clots, skin, hair, viscera and bruised/disintegrated material.

The product shall be cured with a mixture of edible common salt and sodium nitrite. The product shall be freefrom added colour flavour and meat tenderized. The packing medium and other ingredients shall be of food gradequality.

The product shall be packed in hermetically sealed clean and sound tin containers and subjected to adequateheat treatment followed by rapid cooling to ensure that the product it shelf stable. The sealed containers shall notshow any change on incubation at 350C for 10 days and 550C for 5 days.

The contents shall have the characteristic colour, free from objectionable odour, discolouration and excessivedisintegration.

The product shall conform to the following requirements, namely:—

Sl. No. Characteristics Requirements

(1) Total Plate Count 1000 / gram maximum

(2) E.Coli Absent in 25 gram

(3) Salmonella Absent in 25 gram

(4) Staphylococcus aureus Absent in 25 gram

(5) Clostridium perfringens and Clostridium Botulinum Absent in 25 gram

Page 170: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 579

6. CANNED MUTTON AND GOAT MEAT means the product prepared from edible portion of meat ofBovine animals slaughtered in an abattoir, which have been subjected to antimortem and postmortem inspection.The product shall be free from bones, blood clots, skin, hair, strings and fibrous tissue, bruised material, viscera,tendons and excessive fat.

The product shall be cut into pieces of reasonably uniform size and cured with a mixture of edible salt andsodium nitrate and or sodium nitrite. The product shall be free from added colour, flavour and meat tenderizer. Thepacking medium and other ingredients shall be of food grade quality.

The product shall be packed in hermetically sealed clean and sound tin containers and subjected to adequateheat treatment followed by rapid cooling to ensure that the product is shelf stable. The sealed container shall notshow any change on incubation at 350C for 10 days and 550C for 5 days.

The contents shall have characteristic colour, free from objectionable odour, discoloration and excessivedisintegration.

The product shall conform to the following requirements, namely:—

Sl. No. Characteristics Requirements

(1) Total plate count 1000 / gram maximum

(2) E.Coli Absent in 25 gram

(3) Salmonella Absent in 25 gram

(4) Staphylococcus aureus Absent in 25 gram

(5) Clostridium perfringens and Clostridium Botulinum Absent in 25 gram

(7) FROZEN MUTTON, GOAT BEEF AND BUFFALO MEAT means the product prepared from edible portionof meat of Bovine animals including buffalo meat slaughtered in an abattoir, which have been subjected to antimortemand postmortem inspection.

The fresh meat meant for freezing shall be clean, free from any foreign matter, objectionable odour/flavour andevidence of deterioration. Meat shall be prepared by quickly freezing in an appropriate equipment in such a way thatthe range of temperature of maximum crystallization is passed quickly and the product attains a temperature of - 180Cor colder at the thermal centre after thermal stabilization. The product shall be kept deep frozen so as to maintain itsquality during transportation, storage and sale.

The product shall conform to the following requirements, namely:—

Sl. No. Characteristics Requirements

(1) Total Plate Count 100000 / gram maximum

(2) E.Coli 100 / gram maximum

(3) Staphylococcus aureus 100 / gram maximum

(4) Clostridium perfringens and 30/ gram maximum

Clostridium Botulinum

(5) Yeast and mould count 1000/ gram maximum

(6) Salmonella Absent in 25 gram

(7) Listeria monocytogenes Absent in 25 gram

PART 5.6. Fish and Fish Products:

Regulation 5.6.1 Fish and Fish Products

(1) Frozen Shrimps or Prawns means the product prepared from fresh shrimps of sound quality belonging toPenaeidae, Pandalidae, Crangonidae, Palaeomonidae Solenoceridae, Aristeidae and Sergestidae families. The product

Page 171: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

580 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

shall not contain a mixture of genera but may contain mixture of species of same genus with similar sensoryproperties. The product may be peeled or unpeeled, raw or cooked. The product may be glazed with water. Theproduct shall conform to the following requirements:—

S.No. Characteristics Requirements in RawProduct Requirement in CookedProduct

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/100 gm Absent in 25gm

(2) Frozen Lobsters means the product prepared from fresh lobsters of sound quality belonging to the genusHomarus of the family Nephropidae and from the families Palinuridae and Scyllaride. The Norway Lobster may beprepared from Nephros norvegicus. The product shall not be a mixture of different species. The product may be rawor cooked. The product may be glazed with water. The product shall conform to the following requirements:—

S.No. Characteristics Requirements in RawProduct Requirement in CookedProduct

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/100 gm Absent in 25gm

(3) Frozen squid and parts of squid means the product prepared from fresh squid of sound quality belongingto squid species of Loliginidae, Ommastrephidae Onychoteuthide and Thysanotenthidae families. The product maybe glazed with water. No food additive is allowed in this product. The product shall conform to the followingrequirements:

S.No. Characteristics Requirements in RawProduct

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/100 gm

(4) Frozen finfish means the product prepared from fresh fish of good quality. The product may be with orwithout head from which viscera or other organs have been completely or partially removed. The product may beglazed with water. The products shall conform to the following requirements:—

S.No. Characteristics Requirements in Raw Product

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/ 100gm

(2) Histamine Not more than 20 mg / 100gm

(5) Frozen fish fillets or minced fish flesh or mixtures thereof are products obtained from fresh wholesomefish of any species or mixtures of species with similar-sensory properties. Fillets may be pieces of irregular size andshape with or without skin. Minced fish flesh consists of particles of skeletal muscle”. and is free from bones,viscera and skin. The product may be glazed with water. The products shall conform to the following requirement:—

S.No. Characteristics Requirements

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/ 100gm

(2) Histamine Not more than 20 mg / 100gm

Note I: Products under article 1, 2, 3, 4 AND 5 shall be frozen in an appropriate equipment quickly to minus(-) 18º C or colder in such a way that the range of temperature of maximum crystallization is passed quickly. The quickfreezing process shall not be regarded as complete unless the product temperature has reached minus (-) 18º C orcolder at the thermal centre after thermal stabilization. The product shall be kept deep frozen so as to maintain thequality during transportation, storage and sale. The entire operation including processing and packaging shallensure minimum dehydration and oxidation. The product may contain food additives permitted in Appendix A exceptlisted product under Regulation 5.6.1 (3). The product shall conform to the microbiological requirement given inAppendix B. The products shall be free from any foreign matter and objectionable odour/flavour.

(6) Dried shark fins means the product prepared from dorsal and pectoral fins, lower lobe of caudal fin andPelvic from fresh shark of edible quality. The product shall be free from adhering flesh and may be with or withoutskin. The product shall be dried in a suitable manner and shall be free from any food additive. The product shall befree from foreign matter, objectionable odour or flavour and rancidity. No food additive is allowed in this product.The products shall conform to the following requirements:—

Page 172: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 581

S.No. Characteristics Requirements

(1) Moisture Not more than 10.0 percent

(2) Ash insoluble in HCl on dry basis Not more than 1.0 percent

(3) Yeast and Mould Count Absent in 25gm

(7) Salted fish/dried salted fish means the product prepared from fresh wholesome fish. The fish shall be bled,gutted, beheaded, split or filleted and washed. The fish shall be fully saturated with salt (Heavy salted) or partiallysaturated to a salt content not less than 10 percent by weight of the salted fish which has been dried. The productshall be free from foreign matter, objectionable odour and flavour. The product may contain food additives permittedin Appendix A. The product shall conform to the microbiological requirement given in Appendix B. The productsshall conform to the following requirements:—

S.No. Characteristics Requirements

(1) Moisture Not more than 16.0 percent

(2) Sodium chloride Not less than 10.0 percent and notmore than 15.0 percent

(3) Ash insoluble in HCl on dry basis Not more than 1.0 percent

(4) Yeast and Mould Count Absent in 25gm

(8) Canned finfish means the product prepared from the flesh of fresh finfish of sound quality belonging toany one species or mixture of species within the same genus having similar sensory properties. The product shall befree from head, tail and viscera. The product may be packed in any suitable packing medium. The packing mediumand other ingredients used shall be of food grade quality. The products shall conform to the following requirements:—

S.No. Characteristics Requirements

(1) Histamine Content Not more than 20 mg/100 gm

(2) Total Volatile Base (Nitrogen) Not more than 30mg/ 100gm

(9) Canned Shrimp means the product prepared from fresh shrimp of sound quality from any combination ofspecies of families Penaeidae, Pandalide, Crangonidae and Palaemonidae from which heads, shell and antenna havebeen removed. The product may be in the form of peeled shrimps which have been headed and peeled withoutremoval of the dorsal tract or cleaned and deveined shrimps in which the back is cut open after peeling and dorsaltract has been removed upto the last segment next to the tail or broken shrimps consisting of pieces of peeled shrimpof less than four segments with or without the vein removed. The packing medium and other ingredients shall be offood grade quality. The products shall conform to the following requirements:—

S.No. Characteristics Requirements

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/100 gm

(2) Acidity in brine expressed as Citric Acid Not more than 0.2 percent

(10) Canned sardines or sardine type products means, the product prepared from fresh or frozen fish belongingto Sardinia pilchardus, Sardinia milanostictusl neopilchardusl ocellatus/sag ax/caeruleus, Sardinia aurita/brasiliensislmaderensisl longicepsl gibbosa celupea harengus, Sprattus sprattus, Hypertophus vittatus, Nematolosaviaminghi,Etrumeus teses, Ethmedium maculatun, Engranulis anchoita/mordax/ringens and opisthonema oglinum.

The product shall be free from head and gills. It may be free from scales and or tail. The fish may be eviscerated.If eviscerated it shall be practically free from visceral parts other than roe milt or kidney. If ungutted it shall bepractically free from undigested feed or used feed. The product shall be packed in any suitable medium. The packingmedium and all other ingredients shall be of food grade quality. The products shall also conform to the followingrequirements:—

Page 173: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

582 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

S.No. Characteristics Requirements

(1) Histamine Content Not more than 20 mg/100 gm

(2) Total Volatile Base (Nitrogen) Not more than 30mg/100 gm

(11) Canned salmon means the product prepared from fresh fish of sound quality belonging to any of thespecies of Salmosalar or Oncorhynctus nerka/kisutchl tschawytscha/gorboscha/ketax and masou species. Theproduct shall be free from head, viscera, fins and tails. The product shall be packed in any suitable medium. Thepacking medium and all other ingredients shall be of food grade quality. No food additive is allowed in this product.The product shall conform to the following requirement.

S.No. Characteristics Requirements in RawProduct

(1) Total Volatile Base (Nitrogen) Not more than 30 mg/100 gm

(12) Canned crab meat means the product prepared from live crabs of sound quality from any of the ediblespecies of the suborder Branchyura or the order Decapoda and all species of the family Lithodiadae. The productshall be prepared singly or in combination from the leg, claw, body and shoulder meat from which the shell has beenremoved. The product shall be packed in any suitable medium. The packing medium and all other ingredients shallbe of food grade quality. The products shall conform to the following requirements:—

S.No. Characteristics Requirements

(1) Total Volatile Base (Nitrogen) Not more than 30mg/100 gm

(2) Acidity in brine expressed as Citric Acid Not less than 0.06 percent andNotmore than 0.2 percent

(13) Canned Tuna and Bonito means the product prepared from fresh fish of sound quality belonging toThunnus alalunga/albacaresl atlanticusl obessul maccoyiil thynnusl tongoe, Euthynnus affinisl alleteratusl Jinlatus/Sarda chilentis/orienlalisl Sarda and Katsuwonus pelamis (syn Euthynnus pelamis) species. The product may be inthe form of segments with or without skin, chunks, flakes or grated / shredded particles. The product shall be packedin any suitable medium. The packing medium and all other ingredients shall be of food grade quality. The productsshall conform to the following requirements:—

S.No. Characteristics Requirements

(1) Histamine Content Not more than 20mg/100 gm

(2) Total Volatile Base (Nitrogen) Not more than 30mg/100 gm

Note II: All the product listed under ARTICLES 8, 9, 10, 11, 12 and 13 shall be packed in hermetically sealed clean andsound containers and subjected to adequate heat treatment followed by rapid cooling to ensure commercialsterility. The container shall be free from rust and mechanical defects. The container shall not show any changeor incubation at 37ºC for 7 days. The final product shall be free from foreign matter, objectionable odour, orflavour. The products may contain food additives permitted in Appendix A except products listed under Regulation5.6.1 (11). The product shall conform to the microbiological requirement given in Appendix B.

Note– Without prejudice to the standards laid down in this Appendix, whenever water is used in the manufacture orpreparation of any article of food, such water shall be free from micro-organisms likely to cause disease and alsofree from chemical constituents which may impair health.

PART 5.7. Sweets & Confectionery:

Regulation 5.7.1 Sugar boiled confectionery:

Sugar boiled confectionery whether sold as hard boiled sugar confectionery or pan goods confectionery ortoffee or milk toffee or modified toffee or lacto-bon-bon or by any other name shall mean a processed compositefood article made from sugar with or without doctoring agents such as cream of tartar by process of boiling whether

Page 174: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 583

panned or not. It may contain centre filling, or otherwise, which may be in the form of liquid, semi-solid or solids withor without coating of sugar or chocolate or both. It may also contain any of the following:—

(i) sweetening agents such as sugar, invert sugar, jaggery, lactose, gur, bura sugar, khandsari, sorbitol,honey, liquid glucose;

(ii) milk and milk products;

(iii) edible molasses;

(iv) malt extracts;

(v) edible starches;

(vi) edible oils and fats;

(vii) edible common salts;

(viii) fruit and fruit products and nut and nut products;

(ix) tea extract, coffee extract, chocolate, cocoa;

(x) vitamins and minerals;

(xi) shellac (food grade) not exceeding 0.4 per cent by weight bee wax (food grade), paraffin wax foodgrade, carnauba wax (food grade), and other food grade wax or any combination thereof;

(xii) edible desiccated coconut;

(xiii) spices and condiments and their extracts;

(xiv) candied peels;

(xv) enzymes;

(xvi) permitted stablizing and emulsifying agents;

(xvii) edible foodgrains; edible seeds;

(xviii) baking powder;

(xix) gulkand, gulabanafsha, mulathi;

(xx) puffed rice;

(xxi) china grass;

(xxii) eucalyptus oil, camphor, menthol oil crystals, pepper mint oil;

(xxiii) thymol;

(xxiv) edible oil seed flour and protein isolates;

(xxv) gum arabic and other edible gum.

It shall also conform to the following standards, namely:—

(i) Ash sulphated (on salt free basis) Not more than 2.5 per cent by weight.

Provided that in case of sugar boiled confectionery where spices are used as centre filling, the ash sulphated shallnot be more than 3 per cent by weight.

(ii) Ash insoluble (in diluteHydrochloric acid) Not more than 0.2 Per cent by weight.

Provided that in case of sugar boiled confectionery where spices are used as centre filling, the ash insolublein dilute Hydrochloric acid shall not be more than 0.4 per cent.

Where the sugar boiled confectionery is sold under the name of milk toffee and butter toffee, it shall conformto the following additional requirements as shown against each;

Page 175: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

584 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(1) Milk toffee—

(i) Total protein (N x 6.25) shall not be less than 3 per cent by weight on dry basis.

(ii) Fat content shall not be less than 4 per cent by weight on dry basis.

(2) Butter toffee- fat content shall not be less than 4 per cent by weight on dry basis.

Provided that it may contain food additives permitted in Table 13 of Appendix A of these regulations.

Provided further that if artificial sweetener has been added as provided in Regulation 4.4.5 (24, 25, 26, 28 &29)

Regulation 5.7.2: Lozenges:

Lozenges shall mean confections made mainly out of pulverised sugar, or icing sugar with binding materialssuch as edible gums, edible gelatine, liquid glucose or dextrin and generally made from cold mixing which does notrequire primary boiling or cooking of the ingredients. It may contain any of the following:—

(i) sweetening agents such as dextrose, dextrosemonohydrate, honey, invert sugar, sugar, jaggery, burasugar, khandsari, sorbitol, liquid glucose;

(ii) milk and milk products;

(iii) nuts and nuts products;

(iv) malt syrup;

(v) edible starches;

(vi) edible common salt;

(vii) ginger powder or extracts;

(viii) cinnamon powder or extracts;

(ix) aniseed powder or extracts;

(x) caraway powder or extracts;

(xi) cardamon powder or extracts;

(xii) cocoa powder or extracts;

(xiii) protein isolates;

(xiv) coffee-extracts or its flavour;

(xv) permitted colour matter;

(xvi) permitted emulsifying and stabilizing agents

(xvii) vitamins and minerals;

It shall also conform to the following standards:

(i) Sucrose content Not less than 85.0 per cent by weight.

(ii) Ash Sulphated (salt free basis) Not more than 3.0 percent by weight

(iii) Ash insoluble in dilute Hydrochloric acid Not more than 0.2 per cent by weight

The product may contain food additives permitted in Appendix A.

Provided that if artificial sweetener has been added in the product, it shall be declared on the label as providedin Regulation 4.4.5 (24, 25, 26, 28 & 29)

Provided further that if only permitted artificial sweetener is used in the products as sweetener, the requirementfor sucrose prescribed in these standards shall not be applicable to such products.

Page 176: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 585

Regulation 5.7.3: Chewing gum and bubble gum

Chewing gum and bubble gum shall be prepared from chewing gum base, or bubble gum base, natural orsynthetic, non-toxic; cane sugar and liquid glucose (corn syrup).

The following sources of gum base may be used:—

(1) Babul, Kikar (gum Arabic)

(2) KHAIR

(3) Jhingan (Jael)

(4) Ghatti

(5) Chiku (Sapota)

(6) Natural rubber latex

(7) Synthetic rubber latex

(8) Glycerol ester of wood resin

(9) Glycerol ester of gum resin

(10) Synthetic resin

(11) Glycerol ester or partially hydrogenated gum or wood resin.

(12) Natural resin

(13) Polyvinyl acetate

(14) Agar (food grade)

It may also contain any of the following ingredients, namely:—

(a) Malt

(b) Milk powder

(c) Chocolate

(d) Coffee

(e) Gelatin, food grade

(f) Permitted Emulsifiers

(g) Water, potable

(h) Nutrients like Vitamins, minerals, proteins

It shall be free from dirt, filth, adulterants and harmful ingredients. it shall also conform to the followingstandards, namely:—

Ingredients Chewing gum Bubble gum

(i) Gum Not less than 12.5per cent by weight Not less than 14.0per cent by weight

(ii) Moisture Not more than 3.5%By weight Not more than 3.5per cent by weight

(iii) Sulphated Ash Not more than 9.5%By weight. Not more than 11.5per cent by weight.

(iv) Acid insoluble ash Not more than 2.0%By weight. Not more than 3.5per cent by weight.

(v) Reducing sugars Not less than 4.5%By weight. Not less than 5.5per cent by weight.(calculated asdextrose)

(vi) Sucrose Not more than 70.0%By weight. Not more than 60.0percent by weight.

Page 177: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

586 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided that it may contain food additives permitted in Table 13 of Appendix A and these regulations.

Provided further, if artificial sweetener has been added as provided in Regulation 6.1.2 (1), it shall bedeclared on the label as provided in Regulation 4.4.5 (24, 25, 26, 28 & 29)

Provided also, that, if only artificial sweetener is added in the product as sweeteners the parameters namely,reducing sugars and sucrose prescribed in the table above shall not be applicable to such product

Regulation 5.7.4: Chocolate

Chocolate means a homogeneous product obtained by an adequate process of manufacture from a mixture ofone or more of the ingredients, namely, cocoa beans, cocoa nib, cocoa mass, cocoa press cake and cocoa dust(cocoa fines/powder), including fat reduced cocoa powder with or without addition of sugars, cocoa butter, milksolids including milk fat The chocolates shall not contain any vegetable fat other than cocoa butter.

The material shall be free from rancidity or off odour, insect and fungus infestation, filth, adulterants and anyharmful or injurious matter.

The chocolates shall be of the following types:—

Milk chocolates is obtained from one or more of cocoa nib, cocoa mass, cocoa press cake, cocoa powderincluding low-fat cocoa powder with sugar and milk solids including milk fat and cocoa butter.

Milk Covering Chocolate - as defined above, but suitable for covering purposes.

Plain Chocolate is obtained from one or more of cocoa nib, cocoa mass, cocoa press cake, cocoa powderincluding low fat cocoa powder with sugar and cocoa butter.

Plain Covering Chocolate-same as plain chocolate but suitable for covering purposes.

Blended Chocolate means the blend of milk and plain chocolates in varying proportions.

White chocolate is obtained from cocoa butter, milk solids, including milk fat and sugar.

Filled Chocolates means a product having an external coating of chocolate with a centre clearly distinctthrough its composition from the external coating, but does not include flour confectionery pastry and biscuitproducts. The coating shall be of chocolate that meets the requirements of one or more of the chocolate typesmentioned above. The amount of chocolate component of the coating shall not be less than 25 per cent of the totalmass of the finished product.

Composite Chocolate-means a product containing at least 60 per cent of chocolate by weight and ediblewholesome substances such as fruits, nuts. It shall contain one or more edible wholesome substances which shallnot be less than 10 per cent of the total mass of finished product.

Provided that it may contain artificial sweeteners as provided in Regulation 4.4.5 (24, 25, 26, 28 & 29)

Provided further that in addition to the ingredients mentioned above, the chocolate may contain one or moreof the substances as outlined below, under different types of chocolates.

(a) edible salts

(b) spices and condiments

(c) permitted emulsifying and stabilizing agents

(d) permitted sequestering and buffering agents.

The product may contain food additives permitted in Appendix A.

Page 178: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 587

Chocolates shall also conform to the following standards namely:—

Sl. Characteristics Requirements for

No. Milk Milk Plain Plain White BlendedChocolate Covering Chocolate Covering Chocolate Chocolate

Chocolate Chocolate

1. Total fat (on dry basis)per cent by weight. Not less than 25 25 25 25 25 25

2. Milk fat (on dry basis) 2 2 - - 2 -Percent by weight.Not less than

3. Cocoa solids 2.5 2.5 12 12 - 3.0(on Moisture-free andfat free basis) percentby weight Not less than

4. Milk Solids (onMoisture- 10.5 - 10.5 - - 10.5 1 9free and fat-free basis)percent by weight.Not less than/not more than - - - - - 9

5. Acid insoluble ash 0.2 0.2 0.2 0.2 0.2 0.2(on moisture fat andsugarfree basis) percentby weight.Not more than

Regulation 5.7.5: Ice Lollies Or Edible Ices

(1) “Ice Lollies or Edible Ices” means the frozen ice produce which may contain sugar, syrup, fruit, fruitjuices, cocoa, citric acid, permitted flavours and colours. It may also contain permitted stabilizers and/or emulsifiersnot exceeding 0.5 per cent by weight. It shall not contain any artificial sweetner.

(2) Ice Candy means the frozen ice produce which may contain fruit, fruit juices, cocoa, nuts, citric acid,permitted flavours and colours. It may also contain permitted stabilizers and/or emulsions not exceeding 0.5 percentby weight. The total sugar expressed as sucrose shall not less than 10 percent by weight. It shall not contain anyartificial sweetener”

Ice Candy means the product obtained by freezing a pasteurized mix prepared from a mixture of water, nutritivesweeteners e.g. sugar, dextrose, liquid glucose, dried liquid glucose, honey, fruits and fruit products, coffee, cocoa,ginger, nuts and salt. The product may contain food additives permitted in these Regulations and Appendices. Itshall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the followingrequirement:—

Total sugars expressed as Sucrose ... Not less than 10.0 percent

Part 5.8: Sweetening agents including Honey

Regulation 5.8.1: Sugar

(1) Plantation White Sugar (commonly known as sugar) means the crystallised product obtained fromsugarcane or sugar beet. It shall be free from dirt, filth, iron filings, and added colouring matter. Extraneous mattershall not exceed 0.1 per cent by weight. It shall also conform to the following standards, namely :—

(a) Moisture (when heated at 105 degree ± 1 degree C for 3 hours) Not more than 0.5 per cent by weight.(b) Sucrose Not less than 98 per cent by weight.

The product may contain food additives permitted in these Regulations and Appendices.

(2) Refined Sugar means the white crystallised sugar obtained by refining of plantation white sugar. It shallbe free from dirt, filth, iron filings and added colouring matter. Extraneous matter shall not exceed 0.1 per cent by

Page 179: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

588 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

weight. It shall also conform to the following standards, namely:—(a) Moisture (when heated at 1050 ± 10 C for 3 hours) Not more than 0.5 per cent by weight.

(b) Sucrose Not less than 99.5 per cent by weight.

The product may contain food additives permitted in these Regulations and Appendices.

(3) Khandsari Sugar obtained from sugarcane juice by open pan process may be of two varieties, namely:

(i) Khandsari Sugar Desi; and

(ii) Khandsari Sugar (sulphur) also known as “Sulphur Sugar”.

It may be crystalline or in powder form. It shall be free from dirt, filth, iron filings and added colouring matter.Extraneous matter shall not exceed 0.25 per cent by weight. It may contain sodium bicarbonate (food grade). It shallalso conform to the following standards, namely:—

Khandsari Sugar (Sulphur Sugar) Khandsari Sugar (Desi)

(i) Moisture (whenz heated at Not more than 1.5 per cent Not more than 1.5 per cent105° ± 1° C for 3 hours) by weight by weight

(ii) Ash insoluble in dilute hydrochloric acid Not more than 0.5 per cent Not more than 0.7 per centby weight. by weight

(iii) Sucrose Not less than 96.5 per cent by weight. Not less than 93.0 per centby weight

The product may contain food additives permitted in these Regulations and Appendices.

Note- Khandsari sugar can be distinguished from plantation white sugar on the following characteristics,namely:

Khandsari Sugar (Sulphur Sugar) Khandsari Sugar (Desi)

(i) Conductivity (106 mho/cm2) 100-300 in 5% solution at 30oC Not more than 100 in 5%solution at 30oC

(ii) Calcium oxide (mg/100gms) Not more than 100 Not more than 50

The product may contain food additives in Appendix A

(4) Bura Sugar means the fine grain size product made out of any kind of sugar. It shall be free from dirt, filth,iron filing and added colouring matter. Extraneous matter shall not exceed 0.1 per cent by weight. It shall alsoconform to the following standards, namely:—

(a) Sucrose Not less than 90.0 per cent by weight.

(b) Ash insoluble in dilute hydrochloric acid Not more than 0.7 per cent by weight.

The product may contain food additives permitted in these Regulations and Appendices.

(5) Cube Sugar means the sugar in the form of cube or cuboid blocks manufactured from refined crystallisedsugar. It shall be white in colour, free from dirt and other extraneous contamination. It shall conform to the followingstandards:—

(a) Sucrose Not less than 99.7 per cent by weight.

(b) Moisture Not more than 0.25 per cent by weight.

(c ) Total ash Not more than 0.03 per cent by weight

The product may contain food additives permitted in these Regulations and Appendices.

(6) Icing Sugar means the sugar manufactured by pulverizing refined sugar or vacuum pan (plantation white)sugar with or without edible starch. Edible starch, if added, shall be uniformly extended in the sugar. It shall be inform of white powder, free from dust, or any other extraneous matter.

Page 180: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 589

The product may contain food additives permitted in these Regulations and Appendices. It shall conform tothe following standards:—

(a) Total starch and sucrose (moisture free) Not less than 99.0 per cent (moisture free) by weight.

(b) Moisture Not more than 0.80 per cent by weight.

(c) Starch Not more than 4.0 percent by weight on dry basis.

Regulation 5.8.2: Misri

(1) Misri means the product made in the form of candy obtained from any kind of sugar or palmyrah juice. It shallbe free from dirt filth, iron filings and added colouring matter. Extraneous matter shall not exceed 0.1 per cent by weight. Itshall also conform to the following standards, namely:—

(a) Total ash Not more than 0.4% by weight

(b) Total Sugar (Called, known or expressed as Sucrose) Not less than 98.0% by weight

The product may contain food additives permitted in these Regulations and Appendices.

Regulation 5.8.3: “Honey”

(1) Honey means the natural sweet substance produced by honey bees from the nectar of blossoms or fromsecretions of plants which honey bees collect, transform store in honey combs for ripening.

When visually inspected, the honey shall be free from any foreign matter such as mould, dirt, scum, pieces ofbeeswax, the fragments of bees and other insects and from any other extraneous matter.

The colour of honey vary from light to dark brown. Honey shall conform to the following standards, namely:—

(a) Specific gravity at 27oC Not less than 1.35

(b) Moisture Not more than 25 per cent by mass

(c) Total reducing sugars Not less than 65.0 per cent by mass

(i) for Carbia colossa and Honey dew Not less than 60 per cent by mass

(d) Sucrose Not more than 5.0 per cent by mass

(i) for Carbia colossa and Honey dew Not more than 10 per cent by mass

(e) Fructose-glucose ratio Not less than 0.95 per cent by mass

(f) Ash Not more than 0.5 per cent by mass

(g) Acidity (Expressed as formic acid) Not more than 0.2 per cent by mass

(h) Fiehe’s test Negative

(i) Hydroxy methyl furfural (HMF), mg/kg Not more than 80

If Fiehe’s test is positive, and hydroxy methyl furfural (HMF) content is more than 80 milligram/kilogram thenfructose glucose ratio should be 1.0 or more.

Regulation 5.8.4: Gur Or Jaggery

(1) Gur or Jaggery means the product obtained by boiling or processing juice pressed out of sugarcane orextracted from palmyra palm, date palm or coconut palm. It shall be free from substances deleterious to health andshall conform to the following analytical standards, on dry weight basis :—

Total sugars expressed as invert sugar Not less than 90 percent and sucrose not less than 60 percent

Extraneous matter Not more than 2 per cent. insoluble in water

Total ash Not more than 6 per cent

Ash insoluble in hydrochloric acid (HCl) Not more than 0.5 per cent

Gur or jaggery other than that of the liquid or semi liquid variety shall not contain more than 10% moisture.

Page 181: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

590 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

The product may contain food additives permitted in these Regulations and Appendices.

Sodium bicarbonate, if used for clarification purposes, shall be of food grade quality.

Regulation 5.8.5: Dextrose

(1) Dextrose is a white or light cream granular powder, odourless and having a sweet taste.

When heated with potassium cupritartarate solution it shall produce a copious precipitate of cuprous oxide.It shall conform to the following standards:—

Sulphated ash Not more than 0.1 per cent on dry basisAcidity 5.0 gm. Dissolved in 50 ml. of freshly boiled and cooled water requires for neutralisation not

more than 0.20 ml. of N/10 sodium hydroxide to phenolphthalein indicator.Glucose Not less than 99.0 per cent on dry basis.

The product may contain food additives permitted in these Regulations and Appendices.

Regulation 5.8.6: Golden Syrup

(1) Golden Syrup means the syrup obtained by inversion of sugar. It shall be golden yellow in colour, pleasantin taste and free from any crystallisation.

It shall conform to the following standards:—Moisture Not more than 25.0 per cent by weightTotal Ash Not more than 2.5 per cent by weightTotal Sugar as invert sugar Not less than 72.0 per cent by weight

The product may contain food additives permitted in these regulations including Appendix A.

Sodium bicarbonate, if used, for clarification purposes, shall be of Food Grade Quality.

Regulation 5.8.7: Saccharin Sodium

(1) Saccharin Sodium commonly known as soluble Saccharin having an empirical formula as C7 H4NNaO3S.2H2O and molecular weight as 241.2 shall be the material which is soluble at 200 C in 1.5 parts of water and50 parts of alcohol (95 per cent); and shall contain not less than 98.0 per cent and not more than the equivalent of100.5 per cent of C7 H4 O3 NSNa calculated with reference to the substance dried to constant weight at 1050 C, assaybeing carried out as presented in Indian Pharmacopoeia. It shall not contain more than 2 p.p.m. of arsenic and 10p.p.m. of lead. The melting point of Saccharin isolated from the material as per Indian Pharmacopoeia method shallbe between 2260 C and 2300 C. The loss on drying of the material at 1050 C shall not be less than 12.0 per cent and notmore than 16.0 per cent of its weight.

The material shall satisfy the tests of identification and shall conform to the limit tests for free acid or alkali,ammonium compounds and parasulpha moylbenzoate as mentioned in the Indian Pharmacopoeia.

Regulation 5.8.8: Aspartyl Phenyl Alanine Methyl Ester (Aspertame)

(1) Aspartyl Phenyl Alanine Methyl Ester commonly known as Aspertame, having empirical formula as C14H18 N2 O5 and molecular weight as 294.31 shall be the material which is slightly soluble in water and Methanole. Itshall contain not less than 98 per cent and not more than 102 per cent of Aspertame on dried basis. It shall notcontain more than 3 ppm of Arsenic and 10 ppm of Lead.

The loss on drying of the material at 1050 C for 4 hours shall not be more than 4.3 per cent of its weight. Thesulphate ash shall not be more than 0.2 per cent. It shall not contain more than 1 per cent of diketo-piper-azine.

Regulation 5.8.9: Acesulfame Potassium

(1) Acesulfame Potassium commonly known as Acesulfame-K, having empirical formula C4H4KNO4S, molecularweight as 201.24 shall be the material which is odourless, white crystalline powder having intensely sweet taste andis very slightly soluble in ethanol but freely soluble in water. It shall contain not less than 99 per cent and not morethan 101 per cent of Acesulfame-K on dried basis. It shall not contain more than 3 ppm. Flouride. Heavy metalscontent shall not be more than 10 ppm. The loss on drying of material at 105 degree centigrade for two hours shallnot be more than 1 percent of its weight.

Page 182: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 591

Regulation 5.8.10: Sucralose

(1) Sucralose:

Chemical name – 1, 6-Dichloro-1, 6-Dideoxy-â-D-Fructofuranosyl-4-Chloro-4-Deoxy-a-D-galactopyranoside;

Synonyms -4, 1 ‘6’-Trichlorogalactosucrose; INS 955

Chemical formula - C12H19CI3O8

Molecular weight- 397.64

It shall be white to off-white, odourless, crystalline powder, having a sweet taste. It shall be freelysoluble in water, in methanol and in alcohol and slightly soluble in ethyl acetate. It shall contain not less than98.0% and not more than 102.0% of C12H19CI3O8 calculated on anhydrous basis. It shall not contain more than3PPM of Arsenic (as AS) and 10PPM or heavy metals (as Pb). It shall not contain more than 0.1% of methanol.Residue on ignition shall not be more than 0.7% and water not more than 0.2%.

Part 5.9: Salt, Spices, Condiments And Related Products

Note: (1) The extraneous matter wherever prescribed, shall be classified as follows:

(a) Organic extraneous matter such as chaff, stems, straw

(b) Inorganic extraneous matter such as dust, dirt, stones and lumpsof earth. This shall not exceed 2 percentby weight of the total Extraneous matter

Regulation 5.9.1: Caraway (Siahjira):

(1) (Siahjira) whole means the mericarps of nearly mature fruit of Carum carvi L. The fruits are split into twomericarps by thrashing after drying. It shall have characteristic flavour and shall be free from extraneous flavour andmustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. It shall befree from attack by Screlotinia mushrooms. It shall be free from added colouring matter and other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Moisture Not more than 13.0 percent by weight

(iii) Total ash on dry basis Not more than 8.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis. Not more than 1.5 percent by weight

(v) Volatile oil content on dry basis Not less than 2.5 percent by (v/w).

(vi) Insect damaged matter Not more than 1.0 percent by weight

Blond Caraway (Carum carvi) whole is slightly larger and its colour is paler.

(2) Caraway Black (Siahjira) Whole means the dried seeds of Carum bulbocastanum. It shall conform to thefollowing standards.

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Moisture Not more than 12.0 percent by weight

(iii) Total ash on dry basis Not more than 9.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(v) Volatile oil content on dry basis Not less than 1.5 percent by (v/w)

(vi) Insect damaged matter Not more than 1.0 percent by weight

(1) Caraway (Siahjira) powder means the powder obtained by grinding the dried mature fruit of Carum CarviL. without addition of any other matter. It may be in the form of small pieces of seeds or in finely ground form. It shallhave characteristic flavour and shall be free from extraneous flavour and mustiness. It shall be free from mould,

Page 183: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

592 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

living and dead insects, insect fragments, rodent contamination. The powder shall be free from added colouringmatter and other harmful substances.

It shall conform to the following standards:—

(i) Moisture Not more than 12.0 percent by weight(ii) Total ash on dry basis Not more than 8.0 percent by weight(iii) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight(iv) VolVolatile oil content on dry basis

Black Not less than 2.25 percent by v/wBlond Not less than 1.33 percent by v/w

Regulation 5.9.2: Cardamom (Elaichi)

(1) Cardamom (Chhoti Elaichi) Whole means the dried capsules of nearly ripe fruits of Elettaria cardamomumL. Maton Var. Minuscula Burkill. The capsules may be light green to brown or pale cream to white when bleachedwith sulphur dioxide. It shall have characteristic flavour free from any foreign odour, mustiness or rancidity. It shallbe free from mould, living and dead insects, insect fragments, rodent contamination. Thrip marks alone should notlead to the conclusion that the capsules have been infested with insects. The product shall be free from addedcolouring matter and other harmful substances.

It shall conform to the following standards:

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Empty and malformed capsules by count Not more than 3.0 percent by count

(iii) Immature and shrivelled capsules Not more than 3.0 percent by weight

(iv) Moisture Not more than 13.0 percent by weight

(v) Total ash on dry basis Not more than 9.5 percent by weight

(vi) Volatile oil content on dry basis Not less than 3.5 percent by v/w

(vii) Insect damaged matter Not more than 1.0 percent by weight

(2) Cardamom (Chhoti Elaichi) seeds means the decorticated seeds separated from the dried capsules ofnearly ripe fruits of Elettaria Cardamomum L. Maton var miniscula Burkill. The seeds shall have characteristicflavour free from foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insectfragments, rodent contamination. The product shall be free from added colouring matter and any other harmfulsubstances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Light seeds Not more than 3.0 percent by weight

(iii) Moisture Not more than 13.0 percent by weight

(iv) Total ash on dry basis Not more than 9.5 percent by weight

(v) Volatile oil content on dry basis Not less than 3.5 percent by v/w

(vi) Insect damaged matter Not more than 1.0 percent by weight

Explanation :- Light seeds mean seeds that are brown or red in colour and broken immature and shrivelledseeds.

(3) Cardamom (Chhoti Elaichi) powder means the powder obtained by grinding dried seeds of ElettariaCardamomum L. Maton var miniscula Burkill without addition of any other substance. It may be in the form of smallpieces of seeds or in finely ground form. It shall have characteristic flavour free from foreign odour, mustiness orrancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powdershall be free from added colouring matter and other harmful substances.

Page 184: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 593

It shall conform to the following standards:—

(i) Moisture Not more than 11.0 percent by weight

(ii) Total ash on dry basis Not more than 8.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 3.0 percent by weight

(iv) Volatile oil content on dry basis Not less than 3.0 percent by v/w.

(4) Large Cardamom (Badi Elaichi) whole means the dried nearly ripe fruit (capsule) of Amomum subulatumRoxb. The capsule shall have characteristic flavour free from foreign odour, mustiness and rancidity. It shall be freefrom mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from addedcolouring matter and any harmful substance.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Empty and malformed capsules by count Not more than 2.0 percent by count

(iii) Immature and shrivelled capsules Not more than 2.0 percent by weight

(iv) Moisture Not more than 12.0 percent by weight

(v) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(vi) Total ash on dry basis Not more than 8.0 percent by weight

(vii) Volatile oil content of seeds on dry basis Not less than 1.0 percent by v/w.

(viii) Insect damaged matter Not more than 1.0 percent by weight

(5) Large Cardamom (Badi Elaichi) seeds means the seeds obtained by decortication of capsules of Amomumsubulatum Roxb. It shall have characteristic flavour free from foreign odour, mustiness and rancidity. It shall be freefrom mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from addedcolouring matter and other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Light seeds / Brown / Red seeds Not more than 3.0 percent by weight

(iii) Moisture Not more than 12.0 percent by weight

(iv) Total ash on dry basis Not more than 8.0 percent by weight

(v) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(vi) Volatile oil content on dry basis Not less than 1.0 percent by v/w

(vii) Insect damaged matter Not more than 1.0 percent by weight.

(6) Large Cardamom (Badi Elaichi) powder means the powder obtained by grinding seeds of Amomumsubulatum Roxb, without the addition of any other substance. It may be in the form of small pieces of seeds or infinely ground form. The powder shall have characteristic flavour free from off flavour, mustiness and rancidity. Itshall be free from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be freefrom added colouring matter and any harmful substance.

It shall conform to the following standards:—

(i) Moisture Not more than 11.0 percent by weight

(ii) Total ash on dry basis Not more than 8.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(iv) Volatile oil content on dry basis Not less than 1.0 percent by weight

Page 185: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

594 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 5.9.3: Chillies and Capsicum (Lal Mirchi)

(1) Chillies and Capsicum (Lal Mirchi) whole - means the dried ripe fruits or pods of the Capsicum annum L& Capsicum frutescens L. The pods shall be free from mould, living and dead insects, insect fragments, rodentcontamination. The product shall be free from extraneous colouring matter, coating of mineral oil and other harmfulsubstances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Unripe and marked fruits Not more than 2.0 percent by weight

(iii) Broken fruits, seed & fragments Not more than 5.0 percent by weight

(iv) Moisture Not more than 11.0 percent by weight

(v) Total ash on dry basis Not more than 8.0 percent by weight

(vi) Ash insoluble in dilute HCl on dry basis Not more than 1.3 percent by weight

(vii) Insect damaged matter Not more than 1.0 percent by weight

(2) Chillies and Capsicum (Lal Mirchi) powder means the powder obtained by grinding clean ripe fruits orpods of Capsicum annum L and Capsicum frutescens L. It shall be free from mould, living and dead insects, insectfragments, rodent contamination. The powder shall be dry, free from dirt, extraneous colouring matter, flavouringmatter, mineral oil and other harmful substances. The chilli powder may contain any edible vegetable oil to amaximum limit of 2.0 percent by weight under a label declaration for the amount and nature of oil used.

It shall conform to the following standards:—

(i) Moisture Not more than 11.0 percent by weight

(ii) Total ash on dry basis Not more than 8.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis Not more than 1.3 percent by weight

(iv) Crude fibre Not more than 30.0 percent by weight

(v) Non-volatile ether extract on dry basis Not less than 12.0 percent by weight

Regulation 5.9.4: Cinnamon (Dalchini)

(1) Cinnamon (Dalchini) whole means the inner bark of trunks or branches of Cinnamomum ZeylanicumBlume. It shall have characteristic odour and flavour and shall be free from foreign flavour and mustiness. It shall befree from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free fromadded colouring matter, foreign vegetable matter and other harmful substances.

It shall conform to the following standards:

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Moisture Not more than 12.0 percent by weight

(iii) Total ash on dry basis Not more than 7.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(v) Volatile oil content on dry basis Not less than 0.7 percent by v/w

(vi) Insect damaged matter Not more than 1.0 percent by weight

(2) Cinnamon (Dalchini) powder means the powder obtained by grinding inner bark of trunk or branches ofCinnamomum Zeylanicum Blume. The powder shall be yellowish to reddish brown in colour with characteristicodour and flavour and shall be free from off flavour and mustiness. It shall be free from mould, living and deadinsects, insect fragments, rodent contamination. The product shall be free from added colouring matter, foreignvegetable matter and other harmful substances.

Page 186: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 595

It shall conform to the following standards:—

(i) Moisture Not more than 12.0 percent by weight

(ii) Total ash on dry basis Not more than 7.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(iv) Volatile oil content on dry basis Not less than 0.5 percent by weight

Regulation 5.9.5: Cassia (Taj)

(1) Cassia (Taj) Whole means the bark of trees of Cinnamomum Cassia (Nees) ex Blume, Cinnamomumaromaticum (Nees) Syn, Cinnamomum burmanii (C.G. Nees) blume and Cinnamomum loureini Nees. The productshall have characteristic odour and flavour and shall be free from off flavour and mustiness. It shall be free frommould, living and dead insects, insect fragments, rodent contamination. The product shall be free from addedcolouring matter, foreign vegetable matter and other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Moisture Not more than 12.0 percent by weight

(iii) Total ash on dry basis Not more than 5.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis Not more than 1.0 percent by weight

(v) Volatile oil content on dry basis Not less than 2.0 percent by v/w.

(2) Cassia (Taj) powder means the powder obtained by grinding bark of trees of Cinnamomum Cassia (Nees)ex Blume, Cinnamomum aromaticum (Nees) Syn, Cinnamomum burmanii (CG Nees) Blume and Cinnamomum loureiniNees without addition of any other matter. The powder shall have characteristic odour and flavour and shall be freefrom off flavour and mustiness. It shall be free from mould, living and dead insects, insect fragments, rodentcontamination. The powder shall be free from added colouring matter, foreign vegetable matter and other harmfulsubstances.

It shall conform to the following standards:

(i) Moisture Not more than 12.0 percent by weight

(ii) Total ash on dry basis Not more than 5.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis Not more than 1.0 percent by v/w

(iv) Volatile oil content on dry basis Not less than 1.5 percent by weight

Regulation 5.9.6: Cloves (Laung)

(1) Cloves (Laung) Whole means the dried unopened flower buds of Eugenia Caryophyllus (C. Sprengel)Bullock and Harrision. It shall be of a reddish brown to blackish brown colour with a strong aromatic odour free fromoff flavour and mustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination.It shall be free from added colouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Tendrils, Mother Cloves Not more than 2.0 percent by weight

(iii) Khokar Cloves Not more than 2.0 percent by weight

(iv) Moisture Not more than 12.0 percent by weight

(v) Volatile oil content on dry basis Not less than 17.0 percent by v/w

(vi) Headless cloves Not more than 2.0 percent by weight

(vii) Insect damaged cloves Not more than 2.0 percent by weight

Page 187: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

596 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Explanation: (1) Headless Cloves: A Clove consisting of only the receptacle and sepals and which has lost thedomed shaped head.

(2) Khoker Cloves: A Clove which has undergone fermentation as a result of incomplete drying as evidencedby its pale brown colour whitish mealy appearance and other wrinkled surface.

(3) Mother Cloves: A fruit in the form of a ovoid brown berry surmounted by four incurved sepals.

(2) Cloves (Laung) powder means the powder obtained by grinding the dried unopened flower buds ofEugenia Caryophyllus (C. Sprengel) Bullock and Harrision without any addition. It shall be of a brown colour witha violet tinge and shall have a strong spicy aromatic odour free from off flavour and mustiness. It shall be free frommould, living and dead insects, insect fragments, rodent contamination. It shall be free from added colouring matter.

It shall conform to the following standards:—

(i) Moisture Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 7.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 0.5 percent by weight

(iv) Volatile oil content on dry basis Not less than 16.0 percent by v/w

(v) Crude Fibre Not more than 13.0 percent by weight

Regulation 5.9.7: Coriander (Dhania)

(1) Coriander (Dhania) whole means the dried mature fruits (seeds) of Coriandrum sativum L. It shall havecharacteristic aroma and flavour. It shall be free from mould, living and dead insects, insect fragments, rodentcontamination. The product shall be free from added colouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Split fruits Not more than 10.0 percent by weight

(iii) Damaged / Discoloured fruits Not more than 2.0 percent by weight

(iv) Moisture Not more than 9.0 percent by weight

(v) Volatile oil content on dry basis Not less than 0.1 percent by v/w

(vi) Total ash on dry basis Not more than 7.0 percent by weight

(vii) Ash insoluble in dilute HCl on dry basis. Not more than 1.5 percent by weight

(viii) Insect damaged matter Not more than 1.0 percent by weight

(2) Coriander (Dhania) powder means the powder obtained by grinding clean, sound, dried mature fruits ofCoriandrum sativum L. It shall be in the form of rough or fine powder. It shall have typical aroma and shall be freefrom mustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination; thepowder shall be free from added colour, starch, bleach or preservative.

It shall conform to the following standards:—

(i) Moisture Not more than 9.0 percent by weight

(ii) Volatile oil content on dry basis Not less than 0.09 percent by v/w

(iii) Total ash on dry basis Not more than 7.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis. Not more than 1.5 percent by weight

Regulation 5.9.8: Cumin (Zeera, Kalonji)

(1) Cumin (Safed Zeera) whole means the dried mature fruits of Cuminum Cyminum L. It shall havecharacteristic aromatic flavour free from mustiness. It shall be free from mould, living and dead insects, insectfragments, rodent contamination. The product shall be free from added colour and harmful substances.

Page 188: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 597

It shall conform to the following standards:—

(i) Extraneous matter Not more than 3.0 percent by weight

(ii) Broken fruits (Damaged, shrivelled, Not more than 5.0 percent by weight

discoloured and immature seed)

(iii) Moisture Not more than 10.0 percent by weight

(iv) Total ash on dry basis Not more than 9.5 percent by weight

(v) Ash insoluble in dilute HCl on dry basis. Not more than 3.0 percent by weight

(vi) Non volatile ether extract on dry basis Not less than 15.0 percent by weight

(vii) Volatile oil content on dry basis Not less than 1.5 percent by v/w

(viii) Proportion of edible seeds other than Absent

cumin seeds

(x) Insect damaged matter Not more than 1.0 percent by weight

(2) Cumin (Safed Zeera) powder means the powder obtained by grinding the dried mature seeds of CuminumCyminum L. It shall have characteristic aromatic flavour free from mustiness. It shall be free from mould, living anddead insects, insect fragments, rodent contamination. The powder shall be free from added colour and harmfulsubstances.

It shall conform to the following standards:—

(i) Moisture Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 9.5 percent by weight

(iii) Acid insoluble ash on dry basis Not more than 1.5 percent by weight

(iv) Non volatile ether extract on dry basis Not less than 15.0 percent by weight

(v) Volatile oil content on dry basis Not less than 1.3 percent by v/w

(3) Cumin Black (Kalonji) whole means the seeds of Nigella sativa L. It shall have characteristic aromaticflavour free from mustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination.The product shall be free from added colour and harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.5 percent by weight

(ii) Broken fruits (Damaged, shrivelled, Not more than 5.0 percent by weightdiscoloured and immature seed)

(iii) Moisture Not more than 10.0 percent by weight

(iv) Total ash on dry basis Not more than 8.0 percent by weight

(v) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight

(vi) Non volatile ether extract on dry basis Not less than 12.0 percent by weight

(vii) Volatile oil content on dry basis Not less than 1.0 percent by v/w

(viii) Edible seeds other than cumin black Not more than 2.0 percent by weight

(ix) Insect damaged matter Not more than 1.0 percent by weight

(4) Cumin Black (Kalonji) powder means the powder obtained by grinding the dried seeds of Nigella sativaL. It shall have characteristic aromatic flavour free from mustiness. It shall be free from mould, living and deadinsects, insect fragments, rodent contamination. The powder shall be free from added colour and harmful substances.

Page 189: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

598 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

It shall conform to the following standards:—

(i) Moisture Not more than 10.0 percent by weight(ii) Total ash on dry basis Not more than 7.0 percent by weight(iii) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight(iv) Volatile oil content on dry basis Not less than 0.9 percent by v/w(v) Non volatile ether extract on dry basis (ml/100gm) Not less than 12.0 percent by weight

Regulation: 5.9.9: Fennel (Saunf)

(1) Fennel (Saunf) whole means the dried ripe fruit of Foeniculum vulgare P. Miller Var. Vulgare. It shall havecharacteristic flavour free from foreign odour, mustiness and rancidity. It shall be free from mould, living and deadinsects, insect fragments, rodent contamination. The product shall be free from added colouring matter and anyharmful substance.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight(ii) Defective seeds Not more than 5.0 percent by weight(iii) Moisture Not more than 12.0 percent by weight(iv) Total ash on dry basis Not more than 10.0 percent by weight(v) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight(vi) Volatile oil content on dry basis Not less than 1.0 percent by v/w(vii) Edible seeds other than fennel Absent(viii) Insect damaged matter Not more than 1.0 percent by weight

(2) Fennel (Saunf) powder means the power obtained by grinding ripe fruits (seeds) of Foeniculum Vulgare P.Miller Var Vulgare. The powder shall have characteristic aromatic flavour free from off flavour, mustiness andrancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powdershall be free from added colouring matter and any harmful substance.

It shall conform to the following standards:—

(i) Moisture Not more than 12.0 percent by weight

(ii) Total ash on dry basis Not more than 9.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 2.0 percent by weight

(iv) Volatile oil content on dry basis Not less than 1.0 percent by v/w

Regulation 5.9.10: Fenugreek (Methi)

(1) Fenugreek (Methi) Whole means the dried mature seeds of Trigonella foenum graecum L. The seeds shallbe free from any off flavour, mustiness and rancidity. It shall be free from mould, living and dead insects, insectfragments, rodent contamination. The product shall be free from added colour, and other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Moisture Not more than 10.0 percent by weight

(iii) Total ash on dry basis Not more than 5.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight

(v) Cold water soluble extract on dry basis Not less than 30.0 percent by weight

(vii) Edible seeds other than fenugreek Not more than 2.0 percent by weight

(viii) Insect damaged matter Not more than 1.0 percent by weight

Page 190: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 599

(2) Fenugreek (Methi) powder means the powder obtained by grinding the dried mature seeds ofTrigonella foenum graecum L. It shall be free from mould, living and dead insects, insect fragments, rodentcontamination. The powder shall be free from added colour and other harmful substances.

It shall conform to the following standards:—

(i) Moisture Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 5.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 1.5 percent by weight

(iv) Cold water soluble extract on dry basis Not less than 30.0 percent by weight

Regulation 5.9.11: Ginger (Sonth, Adrak)

(1) Ginger (Sonth, Adrak) whole means the dried rhizome of Zingiber officinale Roscoe in pieces irregular inshape and size, pale brown in colour with peel not entirely removed and washed and dried in sun. It may be bleachedwith lime. It shall have characteristic taste and flavour free from musty odour or rancid or bitter taste. It shall be freefrom mould, living and dead insects, insect fragments, and rodent contamination. The product shall be free fromadded colouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Moisture Not more than 12.0 percent by weight

(iii) Total ash on dry basis

(a) Unbleached Not more than 8.0 percent by weight

(b) Bleached Not more than 12.0 percent by weight

(iv) Calcium as Calcium oxide on dry basis

(a) Unbleached Not more than 1.1 percent by weight

(b) Bleached Not more than 2.5 percent by weight

(v) Volatile oil content on dry basis Not less than 1.5 percent by v/w

(vi) Insect damaged matter Not more than 1.0 percent by weight

(2) Ginger (Sonth, Adrak) Powder means the powder obtained by grinding rhizome of Zingiber officinaleRoscoe. It shall have characteristic taste and flavour free from musty odour or rancid or bitter taste. It shall be freefrom mould, living and dead insects, insect fragments, and rodent contamination. The powder shall be free fromadded colouring matter.

It shall conform to the following standards:—

(i) Moisture Not more than 12.0 percent by weight

(ii) Total ash on dry basis

(a) Unbleached Not more than 8.0 percent by weight

(b) Bleached Not more than 12.0 percent by weight

(iii) Calcium as Calcium oxide on dry basis

(a) Unbleached Not more than 1.1 percent by weight

(b) Bleached Not more than 2.5 percent by weight

(iv) Volatile oil content on dry basis Not less than 1.5 percent by v/w

(v) Water soluble ash on dry basis Not less than 1.7 percent by weight

(vi) Acid insoluble ash on dry basis Not more than 1.0 percent by weight

(vii) Alcohol (90% v/w) soluble extract on drybasis Not less than 5.1 percent by weight

(viii) Cold water soluble extract on dry basis Not less than 11.4 percent by weight

Page 191: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

600 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 5.9.12: Mace (Jaipatri)

(1) Mace (Jaipatri) whole means the dried coat or aril of the seed of Myristica fragrans Houttuyn. It shall notcontain the aril of any other variety of Myristica nalabarica or Fatua (Bombay mace) and Myristica argenea (Wildmace). It shall have characteristic aromatic flavour free from foreign odour and mustiness. It shall be free from mould,living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouringmatter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 0.5 percent by weight

(ii) Moisture Not more than 10.0 percent by weight

(iii) Total ash on dry basis Not more than 4.0 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis. Not more than 0.5 percent by weight

(v) Volatile oil content on dry basis Not less than 7.5 percent by v/w

(vi) Insect damaged matter Not more than 1.0 percent by weight

(vii) Nutmeg in mace Not more than 1.0 percent by weight

(2) Mace (Jaipatri) powder means the powder obtained by grinding dried coat or aril of the seed of Myristicafragrans Houttuyn. It shall have characteristic aromatic flavour free from foreign odour and mustiness. It shall befree from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be free fromadded colouring matter.

The powder shall conform to the following requirements:—

(i) Moisture Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 3.0 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis Not more than 0.5 percent by weight

(iv) Volatile oil content on dry basis Not less than 5.0 percent by v/w

(v) Crude fibre Not more than 10.0 percent by weight

(vi) Non-volatile ether extract Not less than 20.0 and not more than30.0 percent by weight.

Regulation 5.9.13: Mustard (Rai, Sarson)

(1) Mustard (Rai, Sarson) whole means the dried, clean mature seeds of one or more of the plants of Brassicaalba. (L). Boiss (Safed rai), Brassica compestris L.var, dichotoma (Kali Sarson), Brasssica Compestris, L. Var, yellowSarson, Syn, Brassica compestris L, var glauca (Pili Sarson), Brassica, compestris L. Var. toria (Toria), Barassicajuncea,(L). Coss et Czern (Rai, Lotni) and Brassica nigra (L); Koch (Benarasi rai). It shall be free from mould, living and deadinsects, insect fragments, rodent contamination. The product shall be free from the seeds of Argemone Maxicana L,any other harmful substances and added colouring matter.

It shall conform to the following standards:

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Damaged or Shrivelled seeds Not more than 2.0 percent by weight

(iii) Moisture Not more than 10.0 percent by weight

(iv) Total ash on dry basis Not more than 6.5 percent by weight

(v) Ash insoluble in dilute HCl on dry basis Not more than 1.0 percent by weight

(vi) Non volatile ether extract on dry basis Not less than 28.0 percent by weight

Page 192: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 601

(vii) Violatile oil content on dry basis Not less than 0.3 percent by v/w

(viii) Insect damaged matter Not more than 1.0 percent by weight

(ix) Allyl iso thiocyanate (m/m) on dry basis

(a) B nigra Not less than 1.0 percent by weight

(b) B Juncea Not less than 0.7 percent by weight

(x) P-hydroxybenzyl iso-thiocyanate (m/m) Not less than 2.3 percent by weighton dry basis in sinapist alba

(xi) Argemone seeds Absent

(2) Mustard (Rai, Sarson) powder means the powder obtained by grinding dried, clean mature seeds of one ormore of the plants of Brassica alba. (L). Boiss (Safed rai), Brassica compestris L. var, dischotoma (Kali Sarson),Brassica Compestris, L. Var, (yellow Sarson), Syn, Brassica compestris L, var glauca (Pili Sarson), Brassica, compestrisL. Var. toria (Toria), Barassicajuncea, (L). Coss et Czern (Rai, Lotni) and Brassica nigra (L); Koch (Benarasi rai)without addition of any other matter. It shall have characteristic pungent aromatic flavour free from rancidity andmustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powdershall be free from Argemone maxicana. L and other harmful substances. It shall also be free from added colouringmatter.

It shall conform to the following standards:

(i) Moisture Not more than 7.0 percent by weight

(ii) Total ash on dry basis Not more than 6.5 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis. Not more than 1.0 percent by weight

(iv) Non volatile ether extract on dry basis Not less than 28.0 percent by weight

(v) Volatile oil content on dry basis Not less than 0.3 percent by v/w

(vi) Crude fibre Not more than 8.0 percent by weight

(vii) Starch Not more than 2.5 per cent by weight

(viii) Test for argemone oil Negative

Regulation 5.9.14: Nutmeg (Jaiphal)

(1) Nutmeg (Jaiphal) whole means the dried seed (kernel) of Myristica fragrans Houttuyn. It shall be ofgreyish brown colour but it may be white if it has been subjected to liming. It shall have characteristic aromaticflavour free from foreign odour and mustiness. It shall be free from mould, living and dead insects, insect fragments,and rodent contamination. The product shall be free from added colouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Absent

(ii) Mace in Nutmeg Not more than 3.0 percent by weight

(iii) Moisture Not more than 10.0 percent by weight

(iv) Total ash on dry basis Not more than 3.0 percent by weight

(v) Water insoluble ash on dry basis Not more than 1.5 percent by weight

(vi) Ash insoluble in dilute HCl on dry basis. Not more than 0.5 percent by weight

(vii) Volatile oil content on dry basis Not less than 6.5 percent by v/w

(viii) Calcium content expressed as Calcium Not more than 0.35 percent by weightOxide on dry basis

Page 193: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

602 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Nutmeg (Jaiphal) powder means the powder obtained by grinding the dried seeds (kernel) or Myristicafragrans Houttuyn. It shall have characteristic aromatic flavour free from foreign odour and mustiness. It shall befree from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be free fromadded colouring matter.

It shall conform to the following standards:—

(i) Moisture Not more than 8.0 percent by weight

(ii) Total ash on dry basis Not more than 3.0 percent by weight

(iii) Water insoluble ash on dry basis Not more than 1.5 percent by weight

(iv) Ash insoluble in dilute HCl on dry basis Not more than 0.5 percent by weight

(v) Volatile oil content on dry basis Not less than 6.0 percent by v/w

(vi) Crude Fibre Not more than 10.0 percent by weight

(vii) Non volatile ether extract on dry basis Not less than 25.0 percent by weight

Regulation 5.9.15: Pepper Black (Kalimirch)

(1) Pepper Black (Kalimirch) whole means the dried berries of Piper nigrum L., brown to black in colour witha wrinkled pericarp. The berries are generally picked before complete ripening and may be brown, grey or black incolour. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The productshall be free from added colour, mineral oil and any other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Light Berries Not more than 5.0 percent by weight

(iii) Pinheads or broken berries Not more than 4.0 percent by weight

(iv) Bulk Density (gm/litre) Not less than 490 gm/litre by weight

(v) Moisture Not more than 13.0 percent by weight

(vi) Total ash on dry basis Not more than 6.0 percent by weight

(vii) Non volatile ether extract on dry basis Not less than 6.0 percent by weight

(viii) Volatile oil content on dry basis Not less than 2.0 percent by v/w

(ix) Peperine Content on dry basis Not less than 4.0 percent by weight

(x) Insect damaged matter (percent by weight) Not more than 1.0 percent by weight

Explanation:—

(a) Light Berry means berry that has reached an apparently normal stage of development but the kerneldoes not exist.

(b) Pinhead means berry of very small size that has not developed.

(c) Broken berry means berry that has been separated in two or more parts.

(2) Pepper Black (Kali Mirch) powder means the powder obtained by grinding dried berries of Piper nigrumL without addition to any other matter. It shall have characteristic aromatic flavour free from foreign odour, mustinessor rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powdershall be free from added colouring matter, mineral oil and any other harmful substances.

It shall conform to the following standards:—

(i) Moisture Not more than 12.5 percent by weight

(ii) Total ash on dry basis Not more than 6.0 percent by weight

Page 194: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 603

(iii) Ash insoluble in dilute HCl on dry basis Not more than 1.2 percent by weight

(iv) Crude Fibre on dry basis Not more than 17.5 percent by weight

(v) Non volatile ether extract on dry basis Not less than 6.0 percent by weight

(vi) Volatile oil content on dry basis Not less than 1.75 percent by v/w

(vii) Peperine Content on dry basis Not less than 4.0 percent by weight

(viii) Salmonella absent in 25 gm

(3) Light Black Pepper means the dried berries of Piper nigrum L. dark brown to dark black in colour. It shallbe well dried and free from mould, living and dead insects, insect fragments, rodent contamination.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Other Foreign edible seeds Not more than 2.0 percent by weight

(4) Pinheads shall be wholly derived from the spikes of piper nigrum L. They shall be reasonably dry and freefrom insects. The colour shall be from dark brown to black. It shall be free from added colouring matter.

It shall conform to the following standards:—

Extraneous matter Not more than 1.0 percent by weight

Regulation 5.9.16: Poppy (Khas Khas)

(1) Poppy (Khas Khas) whole means the dried mature seeds of Papaver somniferum L. It may be white orgreyish in colour with characteristic flavour free from off flavour, mustiness and rancidity. It shall be free from mould,living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouringmatter and any other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Moisture Not more than 11.0 percent by weight

(iii) Non volatile ether extract on dry basis Not less than 40.0 percent by weight

Regulation 5.9.17: Saffron (Kesar)

(1) Saffron (Kesar) means the dried stigmas or tops of styles of Crocus Sativus Linnaeus. It shall be dark redin colour with a slightly bitter and pungent flavour, free from foreign odour and mustiness. It shall be free frommould, living and dead insects, insect fragments, rodent contamination. The product shall be free from addedcolouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Floral waste Not more than 10.0 percent by weight

(iii) Moisture and volatile matter at 103 ± ºC Not more than 12.0 percent by weight

(iv) Total ash on dry basis Not more than 8.0 percent by weight

(v) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight

(vi) Solubility in cold water on dry weight Basis Not more than 65.0 percent by weight

(vii) Bitterness expressed as direct reading of Not less than 30.0 percent by weightabsorbance of picrocrocine at about 257 nmon dry basis

Page 195: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

604 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(viii) Safranal expressed as direct reading of Not less than 20.0 percent by weight and not moreabsorbance of 330 nm on dry basis than 50.0 percent by weight

(ix) Colouring strength expressed as direct Not less than 80.0 percent by weightreading of absorbance of 440 nm on dry basis

(x) Total Nitrogen on dry basis Not more than 2.0 percent by weight

(xi) Crude Fibre on dry basis Not more than 6.0 percent by weight

Explanation:- Floral waste means yellow filaments that are unattached and separated pollens, stamens, partsof ovaries and other parts of flowers of Crocus sativus Linnaeus.

(2) Saffron (Kesar) powder means the powder obtained by crushing dried stigmas of Crocus Sativus Linnaeus.It shall be dark red in colour with a slightly bitter and pungent flavour, free from foreign odour and mustiness.

It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powder shallbe free from added colouring matter.

It shall conform to the following standards:—

(i) Moisture and volatile matter Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 8.0 percent by weight

(iii) Acid insoluble ash on dry basis Not more than 1.5 percent by weight

(iv) Solubility in cold water on dry weight basis Not more than 65.0 percent by weight

(v) Bitterness expressed as direct reading of Not less than 30.0 percent by weightabsorbance of picrocrocine at about 257 nmon Dry basis

(vi) Safranal expressed as direct reading of Not less than 20.0 percent by weight and not moreabsorbance of 330 nm on dry basis than 50.0 percent by weight

(vii) Colouring strength expressed as direct reading Not less than 80.0 percent by weightof absorbance of 440 nm on dry basis

(viii) Total Nitrogen on dry basis Not more than 3.0 percent by weight

(ix) Crude Fibre on dry basis Not more than 6.0 percent by weight

Regulation 5.9.18: Turmeric (Haldi)

(1) Turmeric (Haldi) whole means the primary or secondary rhizomes commercially called bulbs or fingers ofCurcuma Longa L. The rhizomes shall be cured by soaking them in boiling water and then drying them to avoidregeneration. The rhizome be in natural state or machine polished. The product shall have characteristic odour andflavour and shall be free from mustiness or other foreign flavours. It shall be free from mould, living and deadinsects, insect fragments, rodent contamination. The product shall be free from Lead Chromate added starch andany other extraneous colouring matter.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 1.0 percent by weight

(ii) Defective Rhizomes Not more than 5.0 percent by weight

(iii) Moisture Not more than 12.0 percent by weight

(iv) Insect damaged matter Not more than 1.0 percent by weight

(v) Test for lead chromate Negative

Explanation :- Defective rhizomes consist of shrivelled fingers and or bulbs internally damaged, hollow orporous rhizomes scorched by boiling and other types of damaged rhizomes.

Page 196: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 605

(2) Turmeric (Haldi) powder means the powder obtained by grinding dried rhizomes or bulbous roots ofCurcuma Longa L. The powder shall have characteristic odour and flavour and shall be free from mustiness or otherforeign odour. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. Thepowder shall be free from any added colouring matter including Lead Chromate and morphologically extraneousmatter including foreign starch.

It shall conform to the following standards:—

(i) Moisture Not more than 10.0 percent by weight

(ii) Total ash on dry basis Not more than 9.0 percent by weight

(iii) Ash insoluble in dil. HCl on dry basis Not more than 1.5 percent by weight

(iv) Colouring power expressed ascurcuminoid Not less than 2.0 percent by weightcontent on dry basis

(v) Total Starch Not more than 60.0 percent by weight

(vi) Test for lead chromate Negative

Regulation 5.9.19: Curry Powder

(1) Curry Powder means the powder obtained from grinding clean, dried and sound spices belonging to thegroup of aromatic herbs and seeds such as black pepper, cinnamon, cloves, coriander, cardamom, chillies, cuminseeds, fenugreek, garlic, ginger, mustard, poppy seeds, turmeric, mace, nutmeg, curry leaves, white pepper, saffronand aniseeds. The material may contain added starch and edible common salt. The proportion of spices used in thepreparation of curry powder shall be not less than 85.0 per cent by weight. The powder shall be free from dirt, mouldgrowth and insect infestation. It shall be free from any added colouring matter and preservatives other than ediblecommon salt.

The curry powder shall also conform to the following standards:—

Moisture Not more than 14.0 percent by weight

Volatile oil Not less than 0.25 percent (v/w) on dry basis

Non-volatile ether extract Not less than 7.5 per cent by weight on dry basis.

Edible common salt Not more than 5.0 per cent by weight on dry basis

Ash insoluble in dilute HCl Not more than 2.0 per cent by weight on dry basis.

Crude Fibre Not more than 15.0 percent by weight on dry basis

Lead Not more than 10.0 p.p.m on dry basis

Regulation 5.9.20: Mixed Masala

(1) Mixed Masala (Whole) means a mixture of clean, dried and sound aromatic herbs and spices. It may alsocontain dried vegetables and/or fruits, oilseeds, garlic, ginger, poppy seeds and curry leaves. It shall be free fromadded colouring matter. It shall be free from mould growth and insect infestation. The proportion of extraneousmatter shall not exceed five per cent by weight, out of which the proportion of organic matter including foreignedible seeds and inorganic matter shall not exceed three per cent and two per cent respectively.

Regulation 5.9.21: Aniseed (Saunf)

(1) Aniseed (Saunf) whole means the dried and mature fruit of Pimpinella anisum L. It shall have characteristicaromatic flavour and shall be free from mustiness. It shall be free from mould, living and dead insects, insectfragments, rodent contamination. The product shall be free from added colouring matter and harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight

(ii) Shrivelled, immature, damaged / insect damaged / Not more than 5.0 percent by weight broken fruit

Page 197: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

606 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(iii) Moisture Not more than 12.0 percent by weight(iv) Total ash on dry basis Not more than 9.0 percent by weight(v) Ash insoluble in dilute HCl on dry basis Not more than 1.5 percent by weight(vi) Volatile oil content on dry basis Not less than 1.0 percent by v/w(vii) Insect damaged matter Not more than 1.0 percent by weight(viii) Foreign edible seeds Not more than 2.0 percent by weight

Regulation 5.9.22: Ajowan (Bishops seed)

(1) Ajowan (Bishops seed) means the dried ripe fruits (seeds) of Trachyspermum ammi. L Sprague. It shall havecharacteristic aromatic flavour and shall be free from mustiness. It shall be free from mould, living and dead insects,insect fragments, rodent contamination. The product shall be free from added colouring matter and any otherharmful substances.

It shall conform to the following standards:—

(i) Moisture Not more than 11.0 percent by weight(ii) Extraneous matter Not more than 2.0 percent by weight(iii) Shrivelled / Damaged / insect damaged / Not more than 2.0 percent by weight

broken fruit(iv) Volatile oil content on dry basis Not less than 1.5 percent v/w

Regulation 5.9.23: Dried Mango Slices

(1) Dried Mango Slices—Means the dried wholesome, edible part of raw mango fruit with or without the outerskin. It shall be free from fungus, moulds and insect infestation, rodent contamination, added colouring, flavouringmatter. It shall also be free from deleterious substances injurious to health. It shall not contain any preservativeexcept edible common salt which may be added to the extent of 5 per cent by weight on dry basis. It shall havecharacteristic taste and flavour. The proportion of extraneous substance shall not exceed 4 per cent by weight outof which inorganic matter shall not exceed 2 per cent by weight.

It shall also conform to the following standards, namely :—

Moisture Not more than 12 per cent by weight.Damaged slices Not more than 5 per cent by weight.Seed Coatings Not more than 6 per cent by weight.Explanation:

(i) Seed coatings shall be exterior covering of the seed.(ii) Damaged slices mean the slices that are eaten by weevils or other insects and includes slices

internally damaged by fungus, moisture or heating.

Regulation: 5.9.24 Dried Mango Powder (Amchur)

(1) Dried Mango Powder (Amchur)—Means the powder obtained by grinding clean and dried mango sliceshaving characteristic taste and flavour. It shall be free from musty odour and objectionable flavour, rodentcontamination, mould, fungus and insect infestation, extraneous matter and added colouring, flavouring matter. Itshall also be free from deleterious substances injurious to health. It shall not contain any preservative except ediblecommon salt which may be added to the extent of 5 per cent by weight on dry basis.

It shall also conform to the following standards, namely:—

(a) Moisture Not more than 12 per cent by Weight(b) Total ash (salt free basis) Not more than 6 per cent by weight(c) Ash insoluble in dilute HCl Not more than 1.5 per cent by weight(d) Crude fibre Not more than 6 per cent by weight(e) Acidity ash anhydrous tartaric acid Not less than 12 per cent and not more than 26

percent by weight

Page 198: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 607

Regulation 5.9.25: Pepper White

(1) Pepper White whole means the dried berries of Piper nigrum L. from which the outer pericap is removedwith or without preliminary soaking in water and subsequent drying, if necessary. The berries shall be light brownto white in colour with a smooth surface. The berries on grinding shall have characteristic aromatic flavour and shallbe free from mustiness. It shall be free from mould, living and dead insects, insect fragments, rodent contamination.The product shall be free from added colouring matter and any other harmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 0.8 percent by weight

(ii) Broken Berries Not more than 3.0 percent by weight

(iii) Black berries Not more than 5.0 percent by weight

(iv) Bulk Density (gm/litre) Not less than 600 percent by weight

(v) Moisture Not more than 13.0 percent by weight

(vi) Total ash on dry basis Not more than 3.5 percent by weight

(vii) Non Volatile ether extract on dry basis Not less than 6.5 percent by weight

(viii) Volatile oil content on dry basis Not less than 1.0 percent by v/w

(ix) Peperine Content on dry basis Not less than 4.0 percent by weight

(x) Insect damaged matter Not more than 1.0 percent by weight

Explanation:- (a) Broken berries means berry that has been separated in two or more parts.

(b) Black Berry means berry of dark colour generally consisting of black pepper berry whose pericarp has notbeen fully removed.

(2) Pepper White powder means the powder obtained by grinding dried berries of Piper nigrum L. from whichthe outer pericarp is removed and to which no foreign matter is added. It shall have characteristic aromatic flavourand shall be free from mustiness. It shall be free from mould, living and dead insects, insect fragments, rodentcontamination. The powder shall be free from added colouring matter and any other harmful substances.

It shall conform to the following standards:—

(i) Moisture Not more than 13.0 percent by weight

(ii) Total ash on dry basis Not more than 3.5 percent by weight

(iii) Ash insoluble in dilute HCl on dry basis Not more than 0.3 percent by weight

(iv) Crude fibre on dry basis Not more than 6.5 percent by weight

(v) Non Volatile ether extract on dry basis Not less than 6.5 percent by weight

(vi) Volatile oil content on dry basis Not less than 0.7 percent by v/w

(vii) Peperine Content on dry basis Not less than 4.0 percent by weight

Regulation 5.9.26: Garlic (Lahsun)

(1) Dried (Dehydrated) Garlic (Lahsun) means the product obtained by drying by any suitable method whichensures characteristics of fresh garlic on rehydration the cloves of Allium sativum L. without bleaching or precooking.It shall be white to pale cream in colour, free from scorched, toasted and baked particles. It may be whole, sliced,quarters, pieces, flakes, kibbled, granules or powdered. The product on rehydration shall have characteristic pungentof odour of garlic, free from off odour, mustiness fermentation and rancidity. It shall be free from mould, living anddead insects, insect fragments, rodent contamination and fungal infection. The products shall be free from addedcolouring matter and any other harmful substances. It shall be free from stalks, peels, stems, and extraneous matter.When in powdered form, it shall be free flowing and free from agglomerates.

Page 199: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

608 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

The products may contain food additives permitted in Appendix – A and it shall conform to the followingstandards, namely:—

(i) Extraneous matter Not more than 0.5 percent

(ii) Moisturea. In case of powdered Garlicb. Not more than 5.0 percent by weight

other than powdered Garlic Not more than 8.0 percent by weight

(iii) Total ash on dry basis Not more than 5.0 percent by dry weight

(iv) Ash insoluble in dil HCl Not more than 0.5 percent by weight

(v) Cold water soluble extract on dry basis Not less than 70.0 and not more than 90.0 percent byweight

(vi) Volatile organic sulphur compound on dry basis Not less than 0.3 percent by weight

(vii) Peroxidase test Negative

Regulation 5.9.27: Celery

(1) Celery whole means the dried ripe fruits (seeds) of Apium graveoleans L. It shall be of uniform colour withcharacteristic aromatic flavour and shall be free from mustiness. It shall be free from mould, living and dead insects,insect fragments, rodent contamination. The product shall be free from added colouring matter and any otherharmful substances.

It shall conform to the following standards:—

(i) Extraneous matter Not more than 2.0 percent by weight(ii) Moisture Not more than 10.0 percent by weight

Regulation 5.9.28: Dehydrated Onion (Sukha Pyaj)

(1) Dehydrated Onion (Sukha Pyaj) – means the product obtained by removal of most moisture by anyacceptable method which ensures characteristics of fresh onions on rehyderation, from sound bulbs of Alliumcepa.L. free from mould, disease, outer skin, leaves and roots. The product may be whole or in the form of slices,rings, flakes, pieces, small grits or powder. The product may be white/cream/pink or red in colour, free from stalks,peals, stems and extraneous matters and scorched particles. The finished product shall be free from discolourationor enzymatic reaction. The product on rehyderation shall be of characteristic flavour, free from foreign and offflavour, mustiness, fermentation and rancid flavour.

It shall be free from mould, living and dead insects, insect fragments and rodent contamination. The productshall be free from added colouring matter and any other harmful substances. When in powdered form, it shall be freeflowing and free from agglomerates.

The products may contain food additives permitted in these regulations including Appendix – A and it shallconform to the following standards, namely:—

Extraneous matter Not more than 0.5 percent by weight

Moisture:

(a) In case of powdered onion Not more than 5.0 percent by weight(b) Other than powdered onion Not more than 8.0 percent by weight

Total Ash on dry basis Not more than 5.0 percent by weightAsh insoluble in dil HCl Not more than 0.5 percent by weightPeroxidase Negative

Regulation 5.9.29 Asafoetida

ASAFOETIDA (Hing or Hingra) means the oleogumresin obtained from the rhizome and roots of Ferulaalliaces, Ferula rubricaulis and other species of Ferula. It shall not contain any colophony resin, galbonum resin,ammoniaccum resin or any other foreign resin. Hing shall conform to the following standards, namely:

Page 200: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 609

(1) Total ash content shall not exceed 15 per cent by weight.

(2) Ash insoluble in dilute hydrochloric acid shall not exceed 2.5 per cent by weight.

(3) The alcoholic extract (with 90 per cent alcohol) shall not be less than 12 per cent as estimated by theU.S.P. 1936 method.

(4) Starch shall not exceed 1 per cent by weight.

Hingra shall conform to the following standards namely:—

(1) The total ash content shall not exceed 20 per cent by weight.

(2) Ash insoluble in dilute hydrochloric acid shall not exceed 8 per cent by weight.

(3) The alcoholic extract (with 90 per cent alcohol) shall not be less than 50 per cent as estimated by theU.S.P. 1936 method.

(4) Starch shall not exceed 1 per cent by weight.

Compounded asafoetida or Bandhani Hing is composed of one or more varieties of asafoetida (Irani orPathani Hing or both) and gum arabic, edible starches or edible cereal flour.

It shall not contain:—

(a) colophony resin,

(b) galbanum resin,

(c) ammoniaccum resin,

(d) any other foreign resin,

(e) coal tar dyes,

(f) mineral pigment,

(g) more than 10 per cent total ash content,

(h) more than 1.5 per cent ash insoluble in dilute hydrochloric acid,

(i) less than 5 per cent alcoholic extract, (with 90 per cent of alcohol) as estimated by the U.S.P.1936 method.

Regulation 5.9.30 Edible Common Salt:

(1) Edible Common Salt means a crystalline solid, white, pale, pink or light grey in colour free from contaminationwith clay, grit and other extraneous adulterant and impurities. It shall not contain moisture in excess of six per centof the weight of the undried sample. The sodium chloride content (as NaCl) and matter soluble in water other thansodium chloride on dry weight basis shall be as specified in columns (2) and (3) of the Table below against the periodof validity mentioned in the corresponding entry in column (1) of the said Table. The matter insoluble in water shallnot exceed 1.0 per cent by weight on dry weight basis.

Period of Validity Minimum percentageof Maximum Percentageof mattersodium chloridecontent solublein water other thanas NaCl(on dry basis) sodium chloride(on dry basis)

Upto 31-3-1982 94.0 5.0From 1-4-1982 to 31-3-1983 94.5 4.5From 1-4-1983 to 31-3-1984 95.0 4.0From 1-4-1984 to 31-3-1985 95.5 3.5From 1-4-1985 onwards 96.0 3.0

The product may contain food additives permitted in Appendix A. The total matter insoluble in water where ananticaking agent has been added shall not exceed 2.2 percent and sodium chloride content on dry basis shall not beless than 97.0 percent by weight.

Page 201: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

610 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Iodised Salt means a crystalline salt, white or pale, pink or light grey in colour, free from contamination withclay, grit and other extraneous adulterants and impurities. It shall conform to the following standards, namely:—

Moisture Not more than 6.0 per cent by weight of the undriedsample.

Sodium Chloride (NaCl) Not less than 96.0 per cent by weight on dry basis.

Matter insoluble in water Not more than 1.0 per cent by weight on drybasis

Matter soluble in water Other than Sodium Chloride Not more than 3.0 per cent by weight on dry basis

Iodine content at—

(a) Manufacture level Not less than 30 parts per million on dry weightbasis

(b) Distribution channelincluding retail level Not less than 15 part permillion on dry weight basis.

The product may contain food additives permitted in Appendix A. The total matter insoluble in water where ananticaking agent has been added shall not exceed 2.2 percent and sodium chloride content on dry basis shall not beless than 97.0 percent by weight.

(3) Iron Fortified Common Salt means a crystalline solid, white or pale, pink or light grey in colour, free fromvisible contamination with clay and other extraneous adulterants and impurities. It shall conform to the followingstandards namely:—

Moisture Not more than 5.0 per cent by weight

Water insoluble matter Not more than 1.0% on dryweight basis.

Chloride content as Nacl Not less than 96.5% by weight on dry weight basis

Matter insoluble in dilute HCl Not more than 3.0 % by weight on dry weight basis,(to be determined by the method specified in IS 253-1970).

Matter soluble in water other than Nacl Not more than 2.5% on dry weight weight basis

Iron content (as Fe) 850-1100 parts per million.

Phosphorous as Inorganic (PO4 ) 1500-2000 parts per million

Sulphate as (SO4) Not more than 1.1% by weight.

Magnesium as (Mg) water soluble Not more than 0.10% by weight

pH value in 5% aqueous Solution 2 to 3.5

The product may contain food additives permitted in Appendix A. The total matter insoluble in water where ananticaking agent has been added shall not exceed 2.2 percent on dry weight basis.

(4) Potassium Iodate means a crystalline powder, white in colour free from impurities. It shall confirm to thefollowing standards namely:—

(1) Potassium Iodate (as KIO3) percent by weight Not less than 99.0

(2) Solubility Soluble in ‘30 Parts of water

(3) Iodine (as I) per cent by wt. not more than 0.002

(4) Sulphate (as SO4) per cent by wt. not more than 0.02

(5. Bromate, bromide, chlorate & chloride percent by wt. not more than 0.01

(6) Matter insoluble in water percent by wt. not more than 0.10

(7) Loss on drying percent by wt. not more than 0.1

Page 202: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 611

(8) PH (5 percent solution) Neutral

(9) Heavy metal (as Pb) ppm not more than 10

(10) Arsenic (as As) ppm not more than 3

(11) Iron (as Fe) ppm not more than 10

PART 5.10: Beverages, (Other than Dairy and Fruits & Vegetables based)

Regulation 5.10.1: Tea

(1) Tea means tea other than Kangra tea obtained by acceptable processes, exclusively from the leaves, budsand tender stems of plant of the Camellia sinensis (L) O. Kuntze. It may be in the form of black or oolong tea. Theproduct shall have characteristic flavour free from any off odour, taint and mustiness. It shall be free from livinginsects, moulds, dead insects, insect fragments and rodent contamination visible to the naked eye (corrected ifnecessary for abnormal vision). The product shall be free from extraneous matter, added colouring matter andharmful substances:

Provided that the tea may contain “natural flavours” and “natural flavouring substances” which are flavourpreparations and single substance respectively, acceptable for human consumption, obtained exclusively by physicalprocesses from materials of plants origin either in their natural state or after processing for human consumption inpackaged tea only. Tea containing added flavour shall bear proper label declaration as provided in Regulation 4.4.5(23). Tea used in the manufacture of flavoured tea shall conform to the standards of tea. The flavoured teamanufacturers shall register themselves with the Tea Board before marketing flavoured tea. Pectinase enzyme can beadded up to a level of 0.2% during manufacture as processing aid. The product shall conform to the followingrequirement in which all the figures given are expressed on the basis of the material oven-dried at 103±2° C.

(a) Total Ash (m/m) Not less than 4.0 percent and not more than 8.0percent

(b) Water Soluble Ash Not less than 45.0 percent of total ash

(c) Alkalinity of water soluble ash expressed Not less than 1.0 percent and not more thanas KOH (m/m) 3.0 percent

(d) Acid-insoluble ash (m/m) Not more than 1.0 percent

(e) Water extract (m/m) Not less than 32.0 percent

(f) Crude Fibre (m/m) Not more than 16.5 percent

(2) Kangra Tea means tea derived exclusively from the leaves, buds and tender stems of plants of the Camelliasinensis or Camellia tea grown in Kangra and Mandi valleys of Himachal Pradesh. It shall conform to the followingspecifications namely;

(a) Total ash determined on tea dried to constant 4.5 to 9.0 percent by weightweight at 1000C

(b) Total ash soluble in boiling distilled water Not less than 34 percent of total ash

(c) Ash insoluble in dilute hydrochloric acid Not more than 1.2 percent by weight on dry basis.

(d) Extract obtained by boiling dried tea Not less than 23 percent. (dried to constant weight at 100OC) with100 parts of distilled water for one hour under Not less than 1.0 percent and not morereflux than 2.2 percent

(e) Alkalinity of soluble ash expressed as K2O on dry basis(f) Crude fibre determined on tea dried to constant Not more than 18.5 percent

weight at 100OC

It shall not contain any added colouring matter It may also contain 0.2 per cent Pectinase enzyme

Page 203: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

612 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided that tea may contain Natural Flavours and Natural Flavouring Substances which are flavourpreparations and single substance respectively, acceptable for human consumption, obtained exclusivley by physicalprocess from materials of plant origin either in their raw state or after processing for human consumption:

Provided further that such tea containing added flavour shall bear proper label declaration as provided inregulation 4.4.5 (23).

Provided also that tea used in the manufacture of flavoured tea shall conform to the standards of tea.

Provided that if tea is sold or offered for sale without any indication as to whether it is Kangra tea or not, thestandards or quality of tea prescribed in item Regulation 5.9.1 (1) shall apply.

Provided also that Flavoured tea manufacturers shall register themselves with the Tea Board before marketingFlavoured tea;

(3) Green Tea means the product derived solely and exclusively, and produced by acceptable processes,notably enzyme, inactivation, rolling or comminution and drying, from the leaves, buds and tender stems of varietiesof the species Camellia sinensis (L) O. Kuntze, known to be suitable for making tea for consumption as a beverage.The product shall have characteristic flavour free from any off odour, taint and mustiness. It shall be free from livingor dead insects, moulds, insect fragments and rodent contamination visible to the naked eye (corrected if necessaryfor abnormal vision). The product shall be free from extraneous matter, added colouring matter and harmful substances;

Provided that the tea may contain “natural flavours” and “natural flavouring substances” which are flavourpreparations and single substance respectively, acceptable for human consumption, obtained exclusively by physicalprocesses from material of plants origin either in their natural state or after processing for human consumption inpackaged tea only. Tea containing added flavour shall bear proper label declaration as provided in regulation 4.4.5(23). Tea used in the manufacture of flavoured tea shall conform to the standards of tea. The flavoured teamanufacturers shall register themselves with the Tea Board before marketing flavoured tea. The product shallconform to the following requirements in which all the figures given are expressed on the basis of the material oven-dried at 103±2° C.

Parameter Limits

(a) Total Ash (m/m) Not less than 4.0 percent and not more than 8.0percent

(b) Water-soluble ash Not less than 45.0 percent of total ash.

(c) Alkalinity of water – solubleAsh expressed Not less than 1.0 percent of total ash and not moreas KOH (m/m) than 3.0 percent

(d) Acid-insoluble ash (m/m) Not more than 1.0 percent(e) Water-extract (m/m) Not less than 32.0 percent(f) Crude fibre (m/m) Not more than 16.5 percent(g) Total catechins (m/m) Not less than 9.0 percent and not more than 19.0

percent

Regulation 5.10.2: Coffee

(1) Coffee (green raw or unroasted) means the dried seeds of Coffea arabica, Coffea liberica, Coffee excelsa orCoffea canephora (robusta) with their husks (mesocarp and endocarp) removed.

1.1 Roasted coffee means properly cleaned green coffee which has been roasted to a brown colour and hasdeveloped its characteristic aroma.

1.2. Ground coffee means the powdered products obtained from ‘roasted coffee’ only and shall be free fromhusk.

1.3. Coffee (green raw or unroasted), ‘roasted and ground coffee’ shall be free from any artificial colouring,flavouring, facing extraneous matter or glazing substance and shall be in sound, dry and fresh condition, free fromrancid or obnoxious flavour.

1.4. Roasted coffee and ground coffee shall conform to the following analytical standards:—

Page 204: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 613

Moisture (on dry basis) m/m Not more than 5.0 percent

Total Ash (on dry basis) m/m 3.0 to 6.0 percent

Acid insoluble ash (on dry basis) m/m Not more than 0.1 percent

Water soluble ash (on dry basis) m/m Not less than 65 percent of total ash

Alkainity of soluble ash in milliliters of Not less than 3.5 ml & Not more than 5.0 ml0.1 N hydrochloric acid per gram of material(on dry basis) m/m

Aqueous extracts on dry basis m/m Not less than 26.0 and not more than 35.0 percent

Caffeine (anhydrous)(on dry basis) m/m Not less than 1.0 percent

(2) Soluble Coffee Powder means coffee powder, obtained from freshly roasted and ground pure coffee beans.The product shall be in the form of a free flowing powder or shall be in the agglomerated form (granules) havingcolour, taste and flavour characteristic of coffee. It shall be free from impurities and shall not contain chicory or anyother added substances.

It shall conform to the following standards:

(i) Moisture (on dry basis) m/m Not more than 4.0 percent

(ii) Total ash (on dry basis) m/m Not more than 12.0 percent

(iii) Caffeined content (on dry basis) m/m Not less than 2.8 percent

(iv) Soulubility in boiling water Dissolves readily in 30 seconds with moderatestirring

(v) Soulubilty in cold water at 16±2oC Soluble with moderate stirring in 3 minutes

Regulation 5.10.3: Chicory

(1) Chicory means the roasted chicory powder obtained by roasting and grinding of the cleaned and driedroots of chicorium intybus Lin with or without the addition of edible fats and oils or sugar, like glucose or sucrosein proportion not exceeding 2.0 percent by weight in aggregate. It shall be free from dirt, extraneous matter, artificialcolouring and flavouring agents.

It shall conform to the following standards, namely:—

(i) Total ash (on dry basis) m/m Not less than 3.5 percent and Not more than 8.0percent

(ii) Acid insoluble ash (on dry basis) m/m Not more than 2.5 percent(iii) Aqueous extracts (on dry basis) m/m Not less than 55.0 percent

Regulation 5.10.4: Coffee – Chicory Mixture

(1) Coffee — Chicory Mixture means the product prepared by mixing roasted and ground coffee and roastedand ground chicory and shall be in a sound, dry and dust free condition with no rancid or obnoxious flavour. It shallbe in the form of a free flowing powder having the colour, taste and flavour characteristic of coffee - chicory powder.It shall be free from any impurities and shall not contain any other added substance. The coffee content in themixture shall not be less than 51 per cent by mass. The percentage of coffee and chicory used shall be marked on thelabel as provided in Regulation 4.4.5 (1) (i)

It shall conform to the following standards, namely:—(i) Moisture Not more than 5.0 per cent.(ii) Total ash on dry basis Not more than 7.50 per cent.(iii) Acid insoluble ash on dry basis Not more than 0.6 per cent.(iv) Caffeine content on dry basis Not less than 0.6 per cent.(v) Aqueous extracts Not more than 50 per cent.

Page 205: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

614 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Instant Coffee — Chicory Mixture means the product manufactured from roasted and ground coffee androasted and ground chicory. It shall be in sound dry and dust free condition with no rancid or obnoxious flavour. Itshall be in the form of a free flowing powder or shall be in the agglomerated (granules) form having the colour, tasteand flavour characteristics of coffee chicory powder. It shall be free from any impurities and shall not contain anyother added substance. The coffee content in the mixture shall not be less than 51 per cent by mass on dry basis.The percentage of coffee and chicory used shall be marked on the label as provided in Regulation 4.4.5 (1) (ii)

It shall conform to the following standards, namely:—

(i) Moisture Not more than 4.0 per cent.

(ii) Total ash on dry basis Not more than 10 per cent.

(iii) Acid insoluble ash on dry basis Not more than 0.6 per cent.

(iv) Caffeine (anhydrous) Not less than 1.4 per cent on dry basis.

(v) Solubility in boiling Dissolves readily in 30 seconds water with moderatestirring

(vi) Solubility in cold water at 16 ± 20C Soluble with moderate stirring in 3 minutes

Regulation 5.10.5 Beverages - Alcoholic

(1) TODDY: Toddy means the sap from coconut, date, toddy palm tree or any other kind of palm tree which hasundergone alcoholic fermentation. It shall be white cloudy in appearance which sediments on storage and shallpossess characteristic flavour derived from the sap and fermentation without addition of extraneous alcohol. It shallbe free from added colouring matter, dirt, other foreign matter or any other ingredient injurious to health. It shall alsobe free from chloral hydrate, paraldehyde, sedative, tranquilizer and artificial sweetener.

It shall also conform to the following standards, namely:

Alcoholic content Not less than 5 percent (v/v)

Total acid as Tartaric acid (expressed in terms of Not less than 400 grams100 litres of absolute alcohol)

Volatile acid as Acetic acid expressed in terms of Not more than 100 grams100 litres of absolute alcohol)

Regulation 5.10.6 Beverages Non-alcoholic - Carbonated

(1) Carbonated Water means water conforming to the standards prescribed for Packaged Drinking Waterunder Food Safety and Standard Act, 2006 impregnated with carbon dioxide under pressure and may contain any ofthe following singly or in combination:

(1) Sugar, liquid glucose, dextrose monohydrate, invert sugar, fructose, honey, fruits and vegetablesextractives and permitted flavouring, colouring matter, preservatives, emulsifying and stabilising agents,citric acid, fumaric acid and sorbitol, tartaric acid, phosphoric acid, lactic acid, ascorbic acid, malic acid, ediblegums such as guar, karaya, arabic carobean, furcellaran, tragacanth, gum ghatti, edible gelatin, albumin,licorice and its derivatives, salts of sodium, calcium and magnesium, vitamins, Caffeine not exceeding 145parts per million, Estergum (Glycerol ester of wood resin) not exceeding 100 parts per million, Gellan Gum atGMP level and quinine salts not exceeding 100 parts per million (expressed as quinine sulphate). It may alsocontain Saccharin Sodium not exceeding 100 ppm or Acesulfame-K not exceeding 300 ppm or Aspertame(methyl ester) not exceeding 700 ppm. or sucralose not exceeding 300 ppm or Neotame not exceeding 33 ppm.

Provided that the quantity of added sugar shall be declared on the container / bottle and if no sugar is addedthat also shall be declared on the container/bottle as laid down in labelling Regulations 4.4.5 (24,25,26, 28 and 29).In case of returnable bottles, which are recycled or refilling the declaration of quantity of added sugar and no sugaradded may be given on the crown.

Provided Also that the declaration of ‘no sugar added’ shall not be applicable for ‘carbonated water (plainsoda)’.

Page 206: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 615

PROVIDED ALSO that the products which contain aspertame, acesulfame or any other artificial sweetner forwhich special labeling provisions have been provided under Regulations 4.4.5 (24,25,26, 28 and 29) of FSS Act,2006, shall not be packed, stored, distributed or sold in returnable containers.

It shall conform to the following requirements, namely—

(1) Total plate count per ml not more than that......50....

(2) Coliform count in 100 ml .......0...........

(3) Yeast and mould count per ml not more than... 2.....

PROVIDED FURTHER estergum used in carbonated water shall have the following standards, namely:—

Glycerol esters of wood rosins commonly known as ester-gum is hard yellow to pale amber coloured solid. Itis a complex mixture of tri and diglycerol esters of resin acids from wood resin. It is produced by the esterification ofpale wood resin with food grade glycerol. It is composed of approximately 90 per cent resin acids and 10 per centneutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpeniod monocarboxylicacids having the typical molecular formula of C20 H30 O2 chiefly abietic acid. The substance is purified by steamstripping or by counter-current steam distillation.

Identification:

Solubility—Insoluble in water, soluble in acetone and in Benzene.

Infra Red Spectrum—Obtain the infra-red spectram of a thin film of the sample deposited on a potassiumbromide plate—scan between 600 and 4000 wave numbers. Compare with typical spectrum obtained from pure ester-gum.

Test for absence of Till oil resin (Sulphur test)—Pass the test as given below:

When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur isconverted to hydrogen sulfide which can readily be detected by the use of lead acetate paper. A positive testindicates the use of till oil resin instead of wood resin.

Apparatus-Test Tube: Use a standard, 10x75 mm, heat-resistant, glass test tube, Burner - Bunsen: A small sizeburner of the microflame type is preferred.

Reagents

Sodium Formate Solution: Dissolve 20g of reagent grade sodium formate, NaOOCH, in 100 ml of distilledwater.

Lead Acetate Test Paper: Commercially available from most chemical supply houses.

Procedure—Weigh 40-50 mg of sample into a test tube and 1-2 drops of sodium formate solution. Place a stripof lead acetate test paper over the mouth of the test tube. Heat the tube in the burner flame until fumes are formedthat contact the test paper. Continue heating for 2-5 minutes. There must be no formation of a black spot of leadsulphide indicating the presence of sulphur containing compounds.

Detection Limit: 50 mg/kg sulphur).

Drop softening point—Between 880 C and 960 C.

Arsenic—Not more than 3ppm.

Lead—Not more than 10ppm.

Heavy metals (as lead)—Not more than 40 ppm.

Acid value— Between 3 and 9.

Hydroxyl number—Between 15 and 45.

Regulation 5.10.7 Mineral water

(1) Mineral water means includes all kinds of Mineral Water or Natural mineral water by whatever name it iscalled and sold.

Page 207: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

616 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(2) Description and Types of Mineral water.

(i) Natural mineral water is water clearly distinguished from ordinary drinking water because —

(a) it is characterized by its content of certain mineral salts and their relative proportions and thepresence of trace elements or of other constituents;

(b) it is obtained directly from natural or drilled sources from underground water bearing strataand not from Public water supply for which all possible precautions should be taken within theprotected perimeters to avoid any pollution of, or external influence on, the chemical and physicalqualities of natural mineral water.

(c) of the constancy of its composition and the stability of its discharge and its temperature, dueaccount being taken of the cycles of minor natural fluctuations;

(d) it is collected under conditions which guarantee the original microbiological purity and chemicalcomposition of essential components;

(e) it is packaged close to the point of emergence of the source with particular hygienic precautions;

(f) it is not subjected to any treatment other than those permitted by this standard;

(ii) Naturally Carbonated Natural Mineral Water - A naturally carbonated natural mineral water is anatural mineral water which, after possible treatment as given hereunder and re-incorporation of gas from thesame source and after packaging taking into consideration usual technical tolerance, has the same content ofcarbondioxide spontaneously and visibly given off under normal conditions of temperature and pressure.

(iii) Non-Carbonated Natural Mineral Water- A non-carbonated natural mineral water is a naturalmineral water which, by nature and after possible treatment as given hereunder and after packaging takinginto consideration usual technical tolerance, does not contain free carbon dioxide in excess of the amountnecessary to keep the hydrogen carbonate salts present in the water dissolved.

(iv) Decarbonated Natural Mineral Water - A decarbonated natural mineral is a natural mineral waterwhich, after possible treatment as given hereunder and after packaging, has less carbon dioxide content thanthat at emergence and does not visibly and spontaneously give off carbon dioxide under normal conditionsof temperature and pressure.

(v) Natural Mineral Water Fortified with Carbon Dioxide from the Source - A natural mineral waterfortified with carbon dioxide from the source is a natural mineral water which, after possible treatment as givenhereunder and after packaging, has more carbon dioxide content than that at emergence.

(vi) Carbonated Natural Mineral Water - A carbonated natural mineral water is a natural mineral waterwhich, after possible treatment as given hereunder and after packaging, has been made effervescent by theaddition of carbon dioxide from another origin.

(2) Treatment and handling:— Treatment permitted includes separation from unstable constituents, such ascompounds containing iron, manganese, sulphur or arsenic, by decantation and/or filtration, if necessary, acceleratedby previous aeration.

The treatments provided may only be carried out on condition that the mineral content of the water is notmodified in its essential constituents, which give the water its properties.

The transport of natural mineral waters in bulk containers for packaging or for any other process beforepackaging is prohibited. Natural Mineral water shall be packaged in clean and sterile containers.

The source on the point of emergence shall be protected against risks of pollution.

The installation intended for the production of natural mineral waters shall be such as to exclude any possibilityof contamination. For this purpose, and in particular —

(a) the installations for collection, the pipes and the reservoirs shall be made from materials suited to thewater and in such a way as to prevent the introduction of foreign substances into the water,

(b) the equipment and its use for production, especially installations for washing and packaging, shallmeet hygienic requirements;

Page 208: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 617

(c) if, during production it is found that the water is polluted, the producer shall stop all operations until thecause of pollution is eliminated;

(d) The related packaging and labelling requirements are provided in the Regulation 4.1.2 , 4.2.1 and 4.4.5

(3) All Mineral Water shall conform to the following standards, namely:—

Sl.No. Characteristic Requirements

(1) (2) (3)

(1) Colour, not more than 2 hazen unit/true colour unit

(2) Odour Agreeable

(3) Taste Agreeable

(4) Turbidity Not more than 2 nephelometric turbidity unit (NTU)

(5) Total Dissolved Solids 150-700 mg/litre

(6) pH 6.5-8.5

(7) Nitrates (as NO3) Not more than 50 mg/litre

(8) Nitrites (as NO2) Not more than 0.02 mg/litre

(9) Sulphide (as H2S) Not more than 0.05 mg/litre Not more than 0.05 mg/litre

(10) Mineral oil Absent

(11) Phenolic compounds (as C6H5OH) Absent

(12) Manganese (as Mn) Not more than 2.0 mg/litre

(13) Copper (as Cu) Not more than 1 mg/litre

(14) Zinc (as Zn) Not more than 5 mg/litre

(15) Fluoride (as F) Not more than 1 mg/litre

(16) Barium (as Ba) Not more than 1.0 mg/litre

(17) Antimony (as Sb) Not more than 0.005 mg/litre

(18) Nickel (as Ni) Not more than 0.02 mg/litre

(19) Borate (as B) Not more than 5 mg/litre

(20) Surface active agents Not detectable

(21) Silver (as Ag) Not more than 0.01 mg/litre

(22) Chlorides (as Cl) Not more than 200 mg/litre

(23) Sulphate (as SO4) Not more than 200 mg/litre

(24) Magnesium (as Mg) Not more than 50 mg/litre

(25) Calcium (as Ca) Not more than 100 mg/litre

(26) Sodium (as Na) Not more than 150 mg/litre

(27) Alkalinity (as HCO3) 75-400 mg/litre

(28) Arsenic (as As) Not more than 0.05 mg/litre

(29) Cadmium (as Cd) Not more than 0.003 mg/litre

(30) Cyanide (as CN) Absent

(31) Chromium (as Cr) Not more than 0.05 mg/litre

Page 209: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

618 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(32) Mercury (as Hg) Not more than 0.001 mg/litre

(33) Lead (as Pb) Not more than 0.01 mg/litre

(34) Selenium (as Se) Not more than 0.05 mg/litre

(35) Poly nuclear aromatic hydrocarbons Not Detectable

(36) Polychlorinated biphenyle Not detectable(PCB)

(37) Pesticide Residue below detectable limits

(38) “Alpha” activity Not more than 0.1 Bacquerel/litre (Bq)

(39) “Beta” activity Not more than 1 Bacquerel/litre (Bq)]

(40) Yeast and mould counts Absent

(41) Salmonella and Shigella Absent

(42) E.Coli or thermotolerant AbsentColiforms1 x 250 ml

(43) Total coliform bacteria AbsentA x 250 ml

(44) Fecal streptococci and AbsentStaphylococcus aureus1 x 250 ml

(45) Pseudomonas aeruginosa Absent1 x 250 ml

(46) Sulphite-reducing anaerobes Absent1 x 50 ml

(47) Vibrocholera Absent1 x 250 ml

(48) V Paraheamolyticus Absent1 x 250 ml

Regulation 5.10.8 Packaged drinking water (other than Mineral water):— means water derived from surface wateror underground water or sea water which is subjected to hereinunder specified treatments, namely, decantation, filteration,combination of filteration, aerations, filteration with membrane filter depth filter, cartridge filter, activated carbon filteration,de-mineralisation, re-mineralisation, reverse osmosis and packed after disinfecting the water to a level that shall not leadto any harmful contamination in the drinking water by means of chemical agents or physical methods to reduce the numberof micro-organisms to a level beyond scientifically accepted level for food safety or its suitability:

Provided that sea water, before being subjected to the above treatments, shall be subjected to desalinationand related processes

The related packaging and labelling requirements are provided in Regulation 4.1.2 , 4.2.1 and 4.4.5

It shall conform to the following standards namely:

Sl.No. Characteristics Requirements

(1) (2) (3)

(1) Colour not more than 2 Hazen Units/ True Colour Units(2) Odour Agreeable

(1) (2) (3)

Page 210: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 619

(3) Taste Agreeable

(4) Turbidity Not more than 2 nephelometric turbidity unit(NTU)

(5) Total Dissolved Solids Not more than 500 mg/litre(6) pH 6.5-8.5(7) Nitrates (as NO3) Not more than 45 mg/litre(8) Nitrites (as NO2) Not more than 0.02 mg/litre(9) Sulphide (as H2S) Not more than 0.05 mg/litre(10) Mineral Oil Absent(11) Phenolic compounds Absent

(as C6H5OH)(12) Manganese (as Mn) Not more than 0.1 mg/litre(13) Copper (as Cu) Not more than 0.05 mg/litre(14) Zinc (as Zn) Not more than 5 mg/litre(15) Fluoride (as F) Not more than 1.0 mg/litre(16) Barium (as Ba) Not more than 1.0 mg/litre(17) Antimony (as Sb) Not more than 0.005 mg/litre(18) Nickel (as Ni) Not more than 0.02 mg/litre(19) Borate (as B) Not more than 5 mg/litre(20) Anionic surface active agents Not more than 0.2 mg/litre (as MBAS)(21) Silver (as Ag) Not more than 0.01 mg/litre(22) Chlorides (as Cl) Not more than 200mg/litre(23) Sulphate (as SO4) Not more than 200mg/litre(24) Magnesium (as Mg) Not more than 30 mg/litre(25) Calcium (as Ca) Not more than 75 mg/litre(26) Sodium (as Na) Not more than 200 mg/litre(27) Alkalinity (as HCO3) Not more than 200 mg/litre(28) Arsenic (as As) Not more than 0.05 mg/litre(29) Cadmium (as CD) Not more than 0.01 mg/litre(30) Cyanide (as CN) Absent(31) Chromium (as Cr) Not more than 0.05 mg/litre(32) Mercury (as Hg) Not more than 0.001 mg/litre(33) Lead (as Pb) Not more than 0.01 mg/litre(34) Selenium (as Se) Not more than 0.01 mg/litre(35) Iron (as Fe) Not more than 0.1 mg/litre(36) Poly nuclear aromatic Not detectable

Hydrocarbons(37) Polychlorinated Not detectable

biphenyle (PCB)(38) Aluminium (as Al) Not more than 0.03 mg/litre

(1) (2) (3)

Page 211: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

620 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(39) Residual free chlorine Not more than 0.2 mg/litre(40) (i) Pesticide residues considered individually - Not more than 0.0001 mg/ litre(The analysis shall

be conducted by using Internationally establishedtest methods meeting the residue limits specifiedherein).

(ii) Total pesticide residue - Not more than 0.0005 mg/litre.(The analysis shallbe conducted by Using Internationally establishedtest methods meeting the residue limits specifiedherein).

(41) “Alpha” activity Not more than 0.1 picocurie/Litre (Bq)(42) “Beta” activity Not more than 1 Bacquerel/Litre (Bq)(43) Yeast and mould counts 1 x 250 ml. Absent(44) Salmonella and Shigella 1 x 250 ml Absent(45) E.Coli or thermotolerant bacteria 1 x 250 ml Absent(46) Coliform bacteria 1 x 250 ml Absent(47) Faecal streptococci and Absent

Staphylococus aureus 1 x 250 ml

(48) Pseudomonas aeruginosa1 x 50 ml Absent

(49) Sulphide reducing anaerobes 1*50 Absent

(50) Vibrio cholera andV. parahaemolyticus1 x 250 ml Absent

(51) Aerobic Microbial Count The total viable colony count shall not exceed 100per ml at 200C to 220C in 72 h on agar- agar or on agar- gelatin mixture, and 20 per ml at 370C in 24 h onagar-agar.

PART 5.11 Other Food Product and Ingredients

Regulation 5.11.1 Baking Powder: means a combination capable, under conditions of baking, of yieldingcarbon dioxide and consists of sodium bicarbonate, and acid-reacting material, starch or other neutral material.

The acid-reacting material of baking powder shall be :—

(a) tartaric acid or its salts, or both

(b) acid salts of phosphoric acid, or

(c) acid compounds of aluminium, or

(d) any combination of the foregoing.

When tested, baking powder shall yield not less than 10 per cent of its weight of carbon dioxide.

Regulation 5.11.2 Catechu (Edible) shall be the dried aqueous extract prepared from the heart-wood of AcaciaCatechu. It shall be free from infestation, sand, earth or other dirt and shall conform to the following standards:

(a) 5 ml. of 1 per cent aqueous solution and 0.1 per cent solution of ferric ammonium sulphate shall givea dark green colour, which on the addition of sodium hydroxide solution shall change to purple.

(b) When dried to constant weight at 100oC, it shall not lose more than 16 per cent of its weight.

(c) Water insoluble residue (dried at 100oC) shall not be more than 25 per cent by weight. Water insolublematter shall be determined by boiling water.

(d) Alcohol insoluble Not more than 30 per

(1) (2) (3)

Page 212: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 621

residue in 90 per cent cent by weight.alcohol dried at 100oC(e) Total ash on dry basis Not more than 8 per cent by weight.(f) Ash insoluble in HCl Not more than 0.5 per cent on dry weight basis.

Provided that in case of Bhatti Katha, the ash insoluble in dilute hydrochloric acid on dry basis shall not bemore than 1.5 per cent.

Regulation 5.11.3 GELATIN shall be purified product obtained by partial hydrolysis of collagen, derived fromthe skin, white connective tissues and bones of animals. It shall be colourless or pale yellowish and translucent inthe form of sheets, flakes, shreds or coarse to fine powder. It shall have very slight odour and taste but notobjectionable which is characteristic and boluillon like. It is stable in air when dry but is subject to microbialdecomposition when moist or in soluble. It shall not contain:—

(a) more than 15 per cent moisture;

(b) more than 3.0 per cent of total ash;

(c) more than 1000 parts per million of sulphur dioxide;

(d) less than 15 per cent of nitrogen, on dry weight basis.

Regulation 5.11.4 Silver Leaf (Chandi-ka-warq): food grade-shall be in the form of sheets, free from creasesand folds and shall contain not less than 99.9 per cent of silver.

Regulation 5.11.5 Pan Masala means the food generally taken as such or in conjunction with Pan, it maycontain;—

Betelnut, lime, coconut, catechu, saffron, cardamom, dry fruits, mulethi, sabnermusa, other aromatic herbs andspices, sugar, glycerine, glucose, permitted natural colours, menthol and non prohibited flavours.

It shall be free from added coaltar colouring matter and any other ingredient injurious to health.

It shall also conform to the following standards namely:—

Total ash Not more than 8.0 per cent by weight (on dry basis)Ash insoluble in dilute HCl acid Not more than 0.5 per cent by weight (on dry basis)

Regulation 5.11.6: Low And High Fat Cocoa Powder means the powder which is the partially defatted productderived from the cocoa bean the seed of Theobroma cocoa L. It may be subjected to treatments during manufacturewith alkali and/or magnesium carbonate, bicarbonate, and with tartaric, citric or phosphoric acids. It shall be freefrom rancidity, dirt, filth, insects and insect fragments or fungus infestations.The product may contain food additivespermitted in Appendix A. It shall conform to the following standards:—

Total ash Not more than 14.0 per cent(on moisture and fat free basis).Ash insoluble in dilute HCl Not more than 1.0 per cent(on moisture and fat free basis).Alkalinity of total ash Not more than 6.0 per cent as K2O (on moisture and fat free

basis)Cocoa butter(i) for low fat Not less than 10.0 percent (on moisture free basis)(ii) for high fat Not less than 20.0 percent (on moisture free basis)

Regulation 5.11.7: CAROB POWDER means the powder obtained from the roasted pods of carob (fibbledcarob) of Ceratonia Siliqua (L) Taub. (fam. Leguminosae) and shall be free from husk. It shall be free from anyartificial colouring, flavouring, extraneous matter or glazing substance and shall be in sound, dry and fresh condition,free from rancid or obnoxious flavours. It shall also conform to the following standards, namely:—

Total ash Not more than 1.2 per cent by weight.Acid insoluble matter Not more than 5 per cent by weight.Tannin content Not less than 0.1 per cent and not more than 0.15

percent.

Page 213: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

622 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Part 5.12: Proprietary Food

Regulation 5.12.1

(1) Proprietary food means a food that has not been standardized under these regulations

(2) In addition to the provisions including labelling requirements specified under these regulations, theproprietary foods shall also conform to the following requirements, namely:—

(i) the name and/or category of the food under which it falls in these regulations shall be mentioned onthe label

(ii) the proprietary food product shall comply with all other regulatory provisions specified in theseregulations and in Appendices A & B.

Proprrietary food means a food that has not been standardized under these regulations. These food shallcomply with all regulatory provisions specified in these regulations including labeling requirements andthe provisions of Appendix A and B as applicable. In addition, propreietary food shall also mention on thelabel, the name and/or category of the food under which it falls.

Part 5.13 Irradiation of Food

Regulation 5.13.1: Definitions - For the purpose of this chapter, unless the context otherwise requires:—

(1) ‘Irradiation’ means any physical procedure, involving the intentional exposure of food to ionizing radiations.

(2) ‘Irradiation facility’ means any facility which is capable of being utilized for treatment of food by irradiation.

(3) ‘Irradiated food’ means articles of food subjected to radiation by :—

(i) Gamma Rays;

(ii) X-rays generated from machine sources operated at or below an energy level of 5 million electronvolts; and

(iii) Sub-atomic particles, namely, electrons generated from machine sources operated at or below anenergy level of 10 million electron volts, to dose levels as specified in Schedule I of the Atomic Energy(Control of Irradiation of Food) Rules 1991.

(4) ‘Operator of irradiation facility’ means any person appointed as such by licensee who satisfies thequalifications and requirements as for training specified in Schedule II of the Atomic Energy (Control of Irradiationof Food) Rules, 1991.

Regulation 5.13.2: Dose of Irradiation:

(1) Save as provided in Regulation 5.12.2 (2) no food shall be irradiated.

(2) No article of food permitted for irradiation specified in column 2 of the Table given below shall receive thedose of irradiation in excess of the quantity specified in column 3 of the said Table at the time of irradiation :—

Sl.No. Name of Foods Dose of Irradiation (KGY)

Minimum Maximum Overall average

1 2 3 4 4

1. Onions 0.03 0.09 0.06

2. Spices 6 14 10

3. Potatoes 0.06 0.15 0.10

4. Rice 0.25 1.0 0.62

5. Semolina (Sooji or Rawa),Wheat, atta and Maida 0.25 1.0 0.62

Page 214: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 623

6. Mango 0.25 0.75 0.50

7. Raisins, Figs and Dried Dates 0.25 0.75 0.50

8. Ginger, Garlic and Shallots(Small Onions) 0.03 0.15 0.09

9. Meat and Meat Productsincluding Chicken 2.5 4.0 3.25

10. Fresh Sea foods 1.0 3.0 2.00

11. Frozen Sea foods 4.0 6.0 5.00

12. Dried Sea foods 0.25 1.0 0.62

13. Pulses 0.25 1.0 0.62

(3) Routine quantitative dosimentry shall be made during operation and record kept of such measurement asprovided under Deptt. of Atomic Energy (Control of Irradiation of Food) Rules 1991.

Regulation 5.13.3: Requirement for the process of Irradiation:—

(1) Approval of facilities - No irradiation facility shall be used for the treatment of food unless such facility

(i) has been approved and licensed under the Atomic Energy (Control of Irradiation of Food) Rules,1991.

(ii) complies with the conditions for approval, operation, licence and process control prescribed underthe Atomic Energy (Control of Irradiation of Food) Rules 1991.

(iii) carries out irradiation in accordance with the provisions of the Atomic Energy (Control of Irradiationof Food) Rules,1991.

(2) Foods once irradiated shall not be re-irradiated unless specifically so permitted by the Licensing Authorityfor the Irradiation process control purposes.

(3) No Food/irradiated food shall leave the irradiation facility unless it has been irradiated in accordance withthe provisions of Deptt. of Atomic Energy (Control of Irradiation of Food) Rules, 1991 and a certificate of irradiationindicating the dose of irradiation and the purpose of irradiation is provided by the competent authority.

Regulation 5.13.4: Restrictions on Irradiation of Food:

(1) The irradiation shall conform to the dose limit and the radiation source to the specific conditions prescribedfor each type or category of Food specified for treatment by irradiation, under the Atomic Energy (Control ofIrradiation of Food) Rules, 1991.

(2) Food which has been treated by irradiation shall be identified in such a way as to prevent its beingsubjected to re-irradiation.

(3) The irradiation shall be carried out only by personnel having the minimum qualifications and training asprescribed for the purpose under the Atomic Energy (Control of Irradiation of Food) Rules,1991.

(4) Food once irradiated shall not be re-irradiated unless specifically so permitted under these regulations.

Regulation 5.13.5: Record of Irradiation of Food:

Any treatment of Food by irradiation shall be recorded by an officer authorised by the competent authority asspecified under the Deptt. of Atomic Energy (Control of Irradiation of Food) Rules, 1991 as follows :—

(a) Name of the article;

(b) Licence No.;

(c) Name, address and other details of Licensee;

1 2 3 4 4

Page 215: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

624 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(d) Purpose of Irradiation;

(e) Source of Irradiation;

(f) Date of Irradiation;

(g) Dose of Irradiation;

(h) Serial Number of Batch;

(i) The nature, quality of Food to be irradiated and the Batch number;

(j) Quantity of Food Irradiated;

(k) Physical appearance of article; before and after irradiation;

(l) Type of packaging used during the irradiation treatment and for packing the irradiated food;

Regulation 5.13.6: Standards of Irradiated Food :

The irradiated foods shall comply with all the provisions of the Food Safety and Standards Act and theregulations made thereunder specifying standards of such food.

Regulation 5.13.7: Storage and sale of irradiated food. Save as otherwise provided in these regulations, no personshall irradiate for sale, store for sale, or transport for sale irradiated food.

Regulation 5.13.8: Restriction on sale of Irradiated Food.- Irradiated food shall be offered for sale only in prepackagedconditions.

Regulation 5.13.9: Labelling of Irradiated Food

Irradiated foods shall meet the labeling requirement as provided under Regulation 4.4.4

CHAPTER 6SUBSTANCES ADDED TO FOOD

Part 6.1: Food AdditivesFor the purpose of this regulation “good manufacturing practices (GMP) for use of food additives” means the food

additives used under the following conditions namely(i) the quantity of the additive added to food shall be limited to the lowest possible level necessary to

accomplish its desired effect;(ii) the quantity of the additive becomes a component of food as a result of its uses in the manufacturing,

processing or packaging of a food and which is not intended to accomplish any physical or other technical effect inthe food itself; is reduced to the extent reasonably possible; and

(iii) the additive is prepared and handled in the same way as a food ingredient.

Regulation 6.1.1:

(1) Use of Food Additives in Food Products: The food products may contain food additives as specified inthese Regulations and in Appendix A.

(2) Use of food additives in traditional foods. - The traditional foods namely, - Snacks of Savouries (FriedProducts), such as Chiwda, Bhujia, Dalmoth, Kadubale, Kharaboondi, Spiced and fried dals, banana chips andsimilar fried products sold by any name, Sweets, Carbohydrates based and Milk product based, such as Halwa,Mysore Pak, Boondi Ladoo, Jalebi,Khoya Burfi, Peda, Gulab Jamun, Rasogolla and similar milk product basedsweets sold by any name, Instant Mixes Powders only of Idli mix, dosa mix, puliyogare mix, pongal mix, gulab jamoonmix, jalebi mix, vada mix, Rice and Pulses based Papads, Ready-to-Serve Beverages (tea/coffee based only) maycontain food additives permitted in these regulations and in Table 2 of Appendix A.

(3) Use of additives in Bread, Biscuits - The food products such as Bread and Biscuits, may contain foodadditives permitted in these regulations and in Table 1 of Appendix A.

Page 216: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 625

(4) Use of Food Additives in different foods. - The following food products may contain food additivespermitted in these regulations and in Table 3 of Appendix A, namely:—

(i) Dairy based drinks, flavoured and or fermented (e.g. chocolate milk) cocoa, eggnog-UHT Sterilisedshelf life more than three months), Synthetic soft drink concentrate, mix/fruit based beverage mix, soups,bullions and taste makers, desert jelly, custard powder, jelly crystal, flavour emulsions and flavour paste (foruse in carbonated and non-carbonated beverages);

(ii) Sausages and sausage meat containing raw meat, cereals and condiments.

(iii) Fruit pulp or juice (not dried) for conversions into jam or crystallized glazed or cured fruit orother product;

(iv) Corn Flour and such like starches;

(v) Corn syrup;

(vi) Canned Rasogolla (the cans shall be internally) lacquered with sulphur dioxide resistantlacquer;

(vii) Gelatine;

(viii) Beer;

(ix) Cider;

(x) Alcoholic Wines;

(xi) Non-alcoholic wines;

(xii) Ready-to-Serve beverage;

(xiii) Brewed ginger beer;

(xiv) Coffee Extract;

(xv) Danish tinned caviar;

(xvi) Dried ginger;

(xvii) Flour confectionery;

(xviii) Smoked fish (in wrappers);

(xix) Dry mixes of Rasgollas;

(xx) Preserved Chapaties;

(xxi) Fat Spread;

(xxii) Prunes;

(xxiii) Baked food confections and baked foods;

(xxiv) Flour for baked food;

(xxv) Packed Paneer;

(xxvi) Cakes and Pastries; and

(xxvii) Prepackaged Coconut Water, Canned Rasogula.

Regulation 6.1.2 Colouring Matter

(1) Unauthorized addition of colouring matter prohibited – The addition of colouring matter to any article offood except as specifically permitted by these regulations is prohibited.

(2) Natural colouring matters which may be used – Except as otherwise provided in these Regulations andAppendices, the following natural colouring principles whether isolated from natural colours or produced syntheticallymay be used in or upon any article of food.

Page 217: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

626 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(a) Carotin & Carotenoids including

(i) Beta-carotene;

(ii) Beta-apo 8’- carotenal;

(iii) Methylester of Beta-apo 8’ carotenoic acid,

(iv) Ethylester of Beta-apo 8’ carotenoic acid,

(v) Canthaxanthin;

(b) Chlorophyll;

(c) Riboflavin (Lactoflavin).

(d) Caramel.

(e) Annatto

(f) Saffron

(g) Curucumin or turmeric

Explanation – In the preparation of the solution of annatto colour in oil, any edible vegetable oil listed inChapter 5 to these regulations may be used either singly or in combination and the name of the oil or oils used shallbe mentioned on the label as provided in Regulation 4.4.2(10) herein.

(3) Addition of inorganic colouring matters and pigments prohibited – Inorganic colouring matters andpigments shall not be added to any article of food unless otherwise provided in these Regulations and Appendices

(4) Synthetic food colours which may be used

No Synthetic food colours or a mixture thereof except the following shall be used in food.

Sl Colour Common name Colour index (1956) Chemical classNo.

1. Red Ponceau 4RCarmoisineErythrosine 162551472045430 AzoAzoXanthene

2. Yellow TartrazineSunset Yellow FCF 1914015985 PyrazoloneAzo

3. Blue Indigo CarmineBrilliant Blue FCF 7301542090 IndigoidTriarylmethane

4. Green Fast Green FCF 42053 Triarylmethane

(5) Use of Lake Colours as colourant in foods

Aluminium Lake of Sunset Yellow FCF may be used in powdered dry beverages mix (powdered softdrink concentrate) upto a maximum limit of 0.04 percent by weight. The maximum limit of colour content in finalbeverage for consumption shall not exceed 8.3 ppm and that of aluminium content shall not exceed 4.4 ppm ofthe final beverage for consumption:

Provided that the powdered dry beverages mix (powdered soft drink concentrate) label shall give clearinstruction for reconstitution of product for making final beverage

(6) Use of permitted synthetic food colours prohibited – Use of permitted synthetic food colours in or uponany food other than those enumerated below is prohibited :–

(i) Ice-cream, milk lollies, frozen desserts, flavoured milk, yoghurt, ice-cream mix-powder;

(ii) Biscuits including biscuit wafer, pastries, cakes, confectionery, thread candies, sweets, savouries(dalmoth, mongia, phululab, sago papad, dal biji only);

(iii) Peas, strawberries and cherries in hermetically sealed containers, preserved or processed papaya,canned tomato juice, fruit syrup, fruit squash, fruit crushes, fruit cordial, jellies, jam, marmalade, candiedcrystallised or glazed fruits;

Page 218: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 627

(iv) Non-alcoholic carbonated and non-carbonated ready to serve synthetic beverages includingsynthetic syrups, sharbats, fruit bar, fruit beverages, fruit drinks, synthetic soft-drink concentrates;

(v) Custard powder;

(vi) Jelly crystal and ice-candy;

(vii) Flavour emulsion and flavour paste for use in carbonated or non-carbonated beverages only underlabel declaration as provided in Regulation 4.4.5 (35).

(7) Maximum limit of permitted synthetic food colours – The maximum limit of permitted synthetic foodcolours or mixture thereof which may be added to any food article enumerated in Regulation 6.1.2(6) and AppendixA of these Regulations shall not exceed 100 parts per million of the final food or beverage for consumption, exceptin case of food articles mentioned in clause (c) of Regulation 6.1.2 (6) where the maximum limit of permittedsynthetic food colours shall not exceed 200 parts per million of the final food or beverage for consumption.

(8) Colours to be pure – The colours specified in these Regulations, when used in the preparation of anyarticle of food shall be pure and free from any harmful impurities.

Regulation 6.1.2 Artificial Sweeteners

(1) Use and sale of artificial Sweeteners

Artificial sweeteners mentioned in column 2 of the table below, may be used only in the food articlesmentioned in column 3 and in quantities not exceeding the limits mentioned in column 4 and as per provisioncontained in these Regulations and Appendices and shall bear the label declarations as provided in theRegulation 4.4.5 (24, 25, 26, 27, 28 & 29)

Sl. Name of Artificial Article of food Maximum limit of ArtificialNo. Sweetener sweetener1 2 3 4

I. Saccharin Sodium Carbonated Water 100 ppmSoft Drink Concentrate *100 ppmSupari 4000 ppmPan Masala 8000 ppmPan Flavouring Material 8.0 percentSynthetic Syrup for dispenser 450 ppmSweets (Carbohydrates based and Milkproducts based) : Halwa, Mysore Pak,Boondi Ladoo, Jalebi, Khoya Burfi,Peda, Gulab Jamun, Rasogolla andsimilar milk product based sweets soldby any name. 500 ppmChocolate (White, Milk, Plain,Composite And Filled) 500 ppmSugar based/ Sugar free confectionery 3000 ppmChewing gum /Bubble gum 3000 ppm

II. Aspartame (methylester) Carbonated Water 700 ppm

Soft Drink concentrate *700 ppmBiscuits, Bread, Cakes and Pasteries 2200 ppmSweets (Carbohydrates based and Milkproducts based) : Halwa, Mysore Pak,

Page 219: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

628 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Boondi Ladoo, Jalebi, Khoya Burfi, Peda,Gulab Jamun, Rasogolla and similar milkproduct based sweets sold by any name 200 ppmJam, Jellies, Marmalades 1000 ppmChocolate (White, Milk, Plain, Composite And Filled) 2000 ppmSugar based/ Sugar free confectionery 10000 ppmChewing gum/ Bubble gum 10000 ppmSynthetic Syrup for dispenser 3000 ppmCustard powder mix 1000 ppmVegetarian jelly crystals 3000 ppmFruit Nectar 600 ppmVegetable Nectar 600 ppmIce Cream, Frozen Dessert and Pudding 1000 ppmFlavoured Milk 600 ppmReady to Serve Tea and Coffee Beverages 600 ppmYoghurt 600 ppmReady to eat Cereals 1000 ppmNon-Carbonated water based beverages (non-alcoholic) 600 ppm

III. Acesulfame Potassium Carbonated water 300 ppmSoft Drink concentrate *300 ppmBiscuits, Bread, Cakes and Pasteries 1000 ppmSweets (Carbohydrates based and Milk products based) :Halwa, Mysore Pak, Boondi Ladoo, Jalabi, Khoya Burfi,Peda, Gulab Jamun, Rasogolla and similar milk productbased sweets sold by any name 500 ppmChocolate (White, Milk, Plain, Composite and Filled) 500 ppmSugar based/ Sugar free confectionery 3500 ppmChewing gum/ Bubble gum 5000 ppmSynthetic Syrup for dispenser 1500 ppmReady to serve tea and coffee based Beverages 600 ppmIce lollies / ice candy 800 ppmcereal based beverages 500 ppmFruit Nectars 300ppmConcentrate for fruit nectars 300 ppm (in final

Beverage forconsumption)

Non carbonated water based beverages (non alcoholic) 300 ppmIV. Sucralose Carbonated water 300 ppm

Soft drink concentrate *300 ppmBiscuits, breads, cakes and Pastries 750 ppmSweets (Carbohydrates based and Milk products based) :Halwa, Mysore Pak, Boondi Ladoo, Jalebi, Khoya Burfi,

1 2 3 4

Page 220: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 629

Peda, Gulab Jamun, Rasogolla and similar milk productbased sweets sold by any name 750 ppmYoghurts 300 ppmSweetened butter milk 300 ppmIce Cream 400 ppmJam, Jellies and Marmalades 450 ppmFrozen fruit 150 ppmChutney 800 ppmConfectionery 1500 ppmChewing gum 1250 ppmCookies 750 ppmDoughnuts /scones /muffins 800 ppmCake mixes 700 ppmReady to serve tea and coffee beverages 600 ppmIce lollies/Ice candy 800 ppmVegetable juice 250 ppmVegetable nectar 250 ppmConcentrates for vegetable juice 1250 ppmConcentrate for vegetable nectar 1250 ppmLozenges 1500 ppmNon–carbonated water based beverages (non-alcoholic) 300 ppmJelly Crystals *300 ppmCustard powder/ ready to eat custard dessert *260 ppmChocolate 800 ppm

V. Neotame Carbonated water 33 ppmSoft drink concentrate *33 ppm

Explanation I:—Pan flavouring material refers to the flavouring agents permitted for human consumption tobe used for pan. It shall be labelled as—

“Pan Flavouring Material”

*Explanation II:—Maximum limit of artificial sweetener in the product shall be as in reconstituted beverage orfood or in final beverage or food for consumption, as the case may be. The product label shall give clear instructionfor reconstitution of products for making final beverage or food for consumption as the case may be.

Provided where the artificial sweetener(s) is/are used in carbonated water / sweetened aerated water / fruitbeverage/ carbonated fruit beverage / fruit nectar, the requirement of minimum total soluble solids shall not apply

Provided further that Saccharin Sodium or Aspertame (Methyl ester) or Acesulfame Potassium or Sucraloseor Neotame may be sold individually as Table Top Sweetener and may contain the following carrier or filler articleswith label declaration as provided in Regulation 4.4.5 (24, 25, 26, 27, 28 & 29) namely:—

(i) Dextrose

(ii) Lactose

(iii) Maltodextrin

(iv) Mannitol

1 2 3 4

Page 221: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

630 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(v) Sucrose

(vi) Isomalt

(vii) Citric Acid

(viii) Calcium silicate

(ix) Carboxymethyl Cellulose

(x) Cream of Tartar, IP

(xi) Cross Carmellose sodium

(xii) Colloidal silicone dioxide

(xiii) Glycine

(xiv) L-leucine

(xv) Magnesium stearate IP

(xvi) Purified Talc

(xvii) Poly vinyl pyrrolidone

(xviii) Providone

(xix) Sodium hydrogen carbonate

(xx) Starch

(xxi) Tartaric acid

(xxii) Erythritol .

Provided further also that where sucralose is marketed as Table Top Sweetener, the concentration of sucraloseshall not exceed six mg per tablet or hundred mg of granule.

(2) No mixture of artificial sweeteners shall be added to any article of food or in the manufacture of table topsweeteners.

Provided that in case of carbonated water, softdrink concentrate and synthetic syrup for dispenser, whereinuse of aspertame and acesulfame potassium have been allowed in the alternative, as per Table under Regulation6.1.2 (1), these artificial sweeteners may be used in combination with one or more alternative if the quantity of eachartificial sweetener so used does not exceed the maximum limit specified for that artificial sweetener in column (4) ofthe said Table as may be worked out on the basis of proportion in which such artificial sweeteners are combined. Theproducts containing mixture of artificial sweeteners shall bear the label as provided in Regulation 4.4.5 (28 & 29).

Provided that in carbonated water, the combination of Sucralose and Acesulfame K may be used on ratio notto exceed proportionate levels of the permissible levels allowed for these individual artificial sweeteners in carbonatedwater under level declaration in Regulation 4.4.5 (28 & 29)

Provided further that mixture of Aspertame (methylester) and Acesulfame K (in ratio 2:1) may be marketed astable top sweetener and may contain the carrier or filler articles as mentioned in the proviso given under the table inRegulation 6.1.3 (1) and under label declaration as provided in Regulation 4.4.5 (24, 25, 26, 28 & 29)

Illustration:— In column (3) of the said Table, in carbonated water, Aspertame (Methyl Ester) or AcesulfamePotassium may be added in the proportion of 700 ppm or 300 ppm respectively. If both artificial sweeteners are usedin combination and the proportion of aspertame (Methyl Ester) is 350 ppm, the proportion of Acesulfame Potassiumshall not exceed the proportion of 150 ppm;

(3) No person shall sell table top sweetener except under label declaration as provided in these Regulations.

Provided that aspertame may be marked as a table top sweetener in tablet or granular form in moisture proofpackages and the concentration of aspertame shall not exceed 18 mg per 100 mg of tablet or granules.

Page 222: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 631

(4) Use of Polyols in Foods:

No polyols shall be added to any article of food except those mentioned in the table below, in quantities notexceeding the limits shown against them as per provision contained in Appendix A of these Regulations and shallbear the label declaration as per Regulation 4.4.5 (46)

Sl. No Name of Polyols Article of Food Maximum limit

1. Isomalt (i) Traditional Indian sweets (carbohydrate based and milk GMPbased), halwa, mysore paag, boondi laddoo, jalebi, khoyaburfi, peda, gulab jamun, rasgulla, and similar sweets soldby any name

(ii) Instant sweetmeat mixes(e.g. pongal mix, gulab jamun mix, jalebi mix)

(iii) Bakery products(iv) Jams, jellies and Marmalades(v) Edible Ice (vi) Ice cream, frozen dessert, sweetened yoghurt

2. Erythritol Dairy drinks (chocolate and flavoured milk), Carbonated GMPBeverages, Non-Cabonated Water based Beverages(non-alcoholic), Ice Cream, Yoghurt, Puddings, Non DairyToppings, Bakery Mixes, Cakes, cookies & pastries, Readyto eat breakfast cereals, soft candies, chocolate and hardcandies

3. Maltitol / Maltitol syrup Bakery products, Ice Cream, Frozen Desserts, Jams, Jellies GMP and Marmalades

(5) Use of Polydextrose in Foods

Polydextrose may be used in following food articles as per GMP levels and proper label declaration asprovided in Regulation 4.4.5 (47)

Ice Cream, Frozen Desserts, Cakes, Biscuits, Yoghurt, Whip topping, Sugar boiled Confectionery, Lozenges,Jam, fruit jelly, Traditional Indian sweets (carbohydrate based and milk based), halwa, mysore paag, boondi laddoo,jalebi, khoya Burfi, peda, gulab jamun, rasgulla, and similar sweets sold by any name

Regulation 6.1.3: Preservatives - “preservative” means a substance which when added to food, is capable ofinhibiting, retarding or arresting the process of fermentation, acidification or other decomposition of food.

(1) Classification of Preservatives:

Preservatives shall be divided into following classes :

(a) Class I preservative shall be :—

(i) Common salt.

(ii) Sugar.

(iii) Dextrose.

(iv) Glucose Syrup.

(v) Spices.

(vi) Vinegar or acetic acid.

(vii) Honey

(viii) Edible vegetable oils

Addition of Class I preservatives in any food is not restricted, unless otherwise provided in the regulationsincluding Appendix A.

Page 223: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

632 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided that the article of food to which a Class I preservative has been added conforms to thespecifications laid down in Chapter 5.

(b) Class II preservatives shall be :—

(i) Benzoic acid including salts thereof,

(ii) Sulphurous acid including salts thereof,

(iii) Nitrates or Nitrites of Sodium or Potassium in respect of food like ham, pickled meat,

(iv) Sorbic acid including its sodium, potassium and calcium salts, propionates of calcium orsodium, lactic acid, and acid calcium phosphate.

(v) Nisin

(vi) Sodium and calcium propionate.

(vii) Methyl or propyl Parahydroxy-Benzoate.

(viii) Propionic acid, including esters or salt thereof,

(ix) Sodium diacetate, and

(x) Sodium, potassium and calcium salts of lactic acid.

(2) Use of more than one Class II preservative prohibited.

(i) No person shall use in or upon a food more than one Class II preservative:Provided that where in column (2) of the table given in the Regulation 6.1.3 (3) the use of more

than one preservative has been allowed in the alternative, those preservatives may, notwithstandinganything contained in Regulation 6.1.3 (3) of these Regulations, be used in combination with one ormore alternatives, provided the quantity of each preservative so used does not exceed such number ofparts out of those specified for that preservative in column (3) of the aforesaid table as may be workedout on the basis of the proportion in which such preservatives are combined.

Illustration.—In the group of foods specified in Item 6 of the table given in Regulation 6.1.3 (3)of these Regulations, sulphur dioxide or Benzoic acid can be added in the proportion of 40 parts permillion or 200 parts per million respectively. If both preservatives are used in combination and theproportion of sulphur dioxide is 20 parts per million, the proportion of Benzoic acid shall not exceed theproportion of 100 parts per million.

(3) Use of Class II preservatives restricted.The use of Class II preservatives shall be restricted to the following group of foods in concentration not

exceeding the proportions given below against each.

Sl. No. Article of Food Preservative Parts per million

(1) (2) (3) (4)

1. Sausages and sausage meat containing raw meat, Sulphur dioxide 450cereals and condiments

2. Fruit, fruit pulp, juice (non dried) for conversion into -do- 2,000jam or crystallized grace or curd fruit or other products :(a) Cherries(b) Strawberries and rasberries -do- 2,000(c) Other fruits -do- 1,000

3. Fruit juice concentrate -do- 1,5004. Dried Fruits

(a) Apricots, peaches, apples, pears and other fruits -do- 2000(b) Raisins and Sultanas -do- 750

Page 224: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 633

5. Other non alcoholic wines, squashes, crushes, fruit syrups, Sulphur dioxideor 350cordials, fruit juices and barley water to be used after dilution or Benzoic acid 350600

6. Jam , marmalade, preserve canned cherry and fruit jelly Sulphur dioxide Or 40Benzoic acid 200

7. Crystallized grace or curd fruit (including candied peel) Sulphur dioxide 1508. Fruit and fruit pulp not otherwise specified in the schedule Sulphur dioxide 3509. Plantation white sugar , cube sugar, dextrose, gur, jaggery, misri Sulphur dioxide 7010. Khandsari (Sulphur) and Bura -do- 15011. Refined sugar -do- 4012. Corn flour and such like starches -do- 10013. Corn syrup -do- 45014. Canned Rasgolla (The cans shall be internally lacquered with -do- 100

sulphur dioxide resistant laquer)15. Gelatine -do- 100016. Beer Sulphur dioxide 7017. Cider -do- 20018. Alcoholic Wines -do- 45019. Ready to serve beverages Sulphur dioxide or 70

Benzoic Acid 12020. Brewed ginger beer Benzoic Acid 12021. Coffee extract -do- 45022. Pickles and chutneys made from fruits and vegetables Benzoic Acid or 250

Sulphur dioxide 10023. Tomato and other sauces Benzoic Acid 75024. Pickled meat and bacon Sodium and/or Potassium Nitrite

expressed as Sodium Nitrite 20025. Corned Beef Sodium and/or Potassium Nitrite

expressed as Sodium Nitrite 10026. Meat Food Products Sodium and /or Potassium Nitrite 200

expressed as Sodium NitriteCommercial salt peter (calculated assodium Nitrite) 500

27. Danish tinned caviar Benzoic acid 5028. Dehydrated vegetables Sulphur dioxide 2,00029. Tomato puree and paste Benzoic acid 75030. Syrups and sharbats Sulphur dioxideor 350

Benzoic acid 60031. Dried ginger Sulphur dioxide 2,00032. Cheese or processed cheese Sorbic acid including its sodium,

potassium and calcium salt(calculated as sorbic acid ) 3,000

Nisin 12.533. Flour confectionery Sorbic acid including its sodium, 1,500

potassium and calcium salt(calculated as sorbic acid )

34. Smoked fish (in wrappers) Sorbic acid Onlywrappers

(1) (2) (3) (4)

Page 225: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

634 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

may beimpregnatedwithsorbicacid

35. Dry mixes of rasgullas Sulphur dioxide 100

36. a ) Soups (other than canned ) Sulphur dioxide 150b) Dried Soups Sulphur dioxide 1,500c) Dehydrated soup mix when packed in containers Sulphur dioxide 1,500

other than cans37. Fruits, vegetables , flakes, powder, figs Sulphur dioxide 60038. Flour for baked food Sodium diacetates or 2,500

propionates or 3,200methyl propyl hydroxy benzoate 500

39. Preserved chappatis Sorbic acid 1,500

40. Paneer or channa Sorbic acid and its sodium 2,000potassium or calcium salts(calculated as sorbic acid)

Or

Propionic acid and its sodium 2,000or potassium salts (calculatedas propionic acid)

41. Fat spread Sorbic acid and its sodium 1,000potassium or calcium salts

(calculated as sorbic acid) 1,000

Or

Benzoic acid and its sodium 1,000or potassium salts (calculatedas benzoic acid) or both

42. Jams, jellies, marmalades, preserve, crystallized glazed or Sorbic acid and its sodium 500candid fruits including candid peels fruit bars potassium or calcium

(calculated as sorbic acid)43. Fruit juice concentrates with preservatives for conversion in -do- 100

juices, nectars for ready to serve beverages in bottles/pouchesselling through dispensers

44. Fruit juices (tin , bottles or pouches ) -do- 20045. Nectars, ready to serve beverages in bottles/ -do- 50

pouches selling through dispensers46. Prunes Potassium Sorbate 1000

(calculated as sorbic acid)

(4) Use of Class II preservatives in mixed foods

In a mixture of two or more foods or groups of foods mentioned against each item in the Table underRegulation 6.1.3 (3) of these Regulations the use of Class II preservative or preservatives shall be restrictedto the limit up to which the use of such preservative or preservatives is permitted for the foods or groups offoods contained in such mixture.

(1) (2) (3) (4)

Page 226: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 635

Illustration.—In the food specified in Item 23 of the table given in Regulation 6.1.3 (3) sulphur dioxidecan be added to dehydrated vegetables in the proportion of 2,000 parts per million. If this food is mixed withthe food specified in Item 24 given in the said table, that is to say tomato puree and paste, where benzoic acidis permitted to an extent of 250 p.p.m., then in the mixture containing equal parts of these two foods, theproportion of Sulphur dioxide and Benzoic acid, shall be 1,000 p.p.m. and 125 p.p.m. respectively.

(5) Restriction on use of nitrate and nitrite.

No nitrate or nitrite shall be added to any infant food.

(6) Use of Natamycin for surface treatment of cheese (hard).

Natamycin may be used for surface treatment of cheese (hard) under label declaration as specified inRegulation 4.4.5 (33), subject to the following conditions, namely :—

(i) Maximum level of application of Natamycin shall not exceed 2mg/dm3

(ii) The penetration depth of Natamycin in cheese (hard) shall not exceed 2mm.

(iii) The maximum residue level of Natamycin in the finished cheese (hard) shall not exceed 1mg/dm3

Regulation 6.1.4: Anti-oxidants,

(1) “anti-oxidant’ means a substance which when added to food retards or prevents oxidative deterioration offood and does not include sugar, cereal, oils, flours, herbs and spices;

(2) Restriction on use of anti-oxidants.

No antioxidant other than lecithin, ascorbic acid and tocopherol shall be added to any food unless otherwiseprovided in Chapter 5 and Appendix A of these Regulations

PROVIDED that the following anti-oxidants, not exceeding in concentration mentioned against each, may beadded to edible oils and fats except ghee and butter, namely :—

1 Ethyl Gallate

2 Propyl gallate or mixture thereof 0.01 percent

3 Octyl gallate

4 Octyl gallate Dodecyl gallate

5 Ascorbyl palmitate 0.02 percent

6 Butylated hydroxyanisole (BHA) 0.02 percent

7 Citric Acid 0.01 percent

8 Tartaric acid

9 Gallic acid

10 Resin Guaiace 0.05 percent

11 Tertiary Butyl Hydro Quinone (TBHQ) 0.02 percent

Provided that dry mixes of Rassgollas and vadas may contain Butylated hydroxyanisole (BHA) notexceeding 0.02 per cent calculated on the basis of fat content:

Provided further that anti-oxidants permitted in the Regulation 6.1.4 (2) of these Regulations may beused in permitted flavouring agents in concentration not exceeding 0.01 per cent.

Provided further that wherever Butylated hydroxyanisole (BHA) is used in conjunction with the anti-oxidants mentioned at item Nos. 1 to 4 of the preceeding proviso, the quantity of the mixture shall not exceedthe limit of 0.02 per cent:

Provided further that Ghee and Butter may contain Butylated hydroxyanisole (BHA) in a concentrationnot exceeding 0.02 per cent.

Page 227: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

636 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Provided further that fat spread may contain Butylated hydroxyanisole (BHA) or Tertiary butyl hydroquinone (TBHQ) in a concentration not exceeding 0.02 per cent by weight on fat basis.

Provided further that ready-to-eat dry breakfast cereals may contain Butylated Hydroxanisole (BHA)not exceeding 0.005 percent (50ppm).

Provided further that in ready to drink infant milk substitute, lecithin and ascrobyl palmitate may be used uptomaximum limit of 0.5 gm./100ml. and 1mg./ 100ml. respectively.

Provided further that chewing gum/ bubble gum may contain Butylated hydroxyanisol (BHA) not exceeding250 ppm.

3. Use of anti-oxidants in Vitamin D Preparation: Vitamin D preparation may contain anti-oxidants prescribedin Regulation 6.1.4 (2) of these Regulations not exceeding 0.08 per cent.

Regulation 6.1.5: Emulsifying and Stabilising agents

1. Emulsifying agents’ and “stabilising agents” means substances which when added to food, are capableof facilitating a uniform dispersion of oils and fats in aqueous media or vice versa, and/or stabilising such emulsionsand include the agents specified below and in Chapter 5 and Appendix A of these regulaitons:

Agar, alginic acid, calcium and sodium alginates, carrageen, edible gums (such as guar, karaya, arabic,carobean, furcellaran, tragacanth, gum ghatti), dextrin, sorbitol, pectin, sodium and calcium pectate, sodiumcitrate, sodium phosphates, sodium tartrate, calcium lactate, lecithin, albumen, gelatin, quillaia, modifiedstarches, hydrolysed proteins, monoglycerides or diglycerides of fatty acids, synthetic lecithin, propyleneglycolstearate, propylenegelycol alginate, methyl ethyl cellulose, methyl cellulose, sodium carboxy-methyl cellulose,stearyl tartaric acid, esters of monoglycerides and diglycerides of fatty acids monostearin sodium sulphoacetate,sorbitan esters of fatty acids or in combination [poly-oxy-ethylene sorbitan, monostearate] sodium stearoyl-2-lactylate and calcium stearoyl-2- lactylate Polyglycerol Esters of fatty acids and polyglycerol Ester ofinteresterified Ricinoleic acid and Glycerol esters of wood rosins (Ester Gum)

2. Restriction on use of emulsifying and stabilizing agents - No emulsifying or stabilising agents shall beused in any food, except where the use of emulsifying or stabilising agent is specifically permitted :

Provided that the following emulsifying or stabilising agents shall not be used in milk and cream, namely :

Monoglycerides or diglycerides of fatty acids, synthetic lecithin, propyl-eneglycol stearate, propyleneglycolalginate, methyl ethyl cellulose, methylcellulose, sodium carboxymethyl cellulose, stearyl tartaric acid, esters ofmonoglycerides and diglycerides of fatty acids, monostearin sodium sulphoacetate, sorbitan esters of fatty acids orin combination

Provided further that Polyglycerol esters of fatty acids and Polyglycerol ester of interesterified Ricinoleicacid may be used in bakery products and in chocolate to the extent of 0.2 per cent by weight.

Provdied that Diacetyl Tartaric acid esters of Mono and Diglycerides may be used in Bread and Cakes.

3. Use of starch phosphate - Starch phosphate, a gum arabic substitute, may be used in syrup, ice-creampowder, salad dressing and pudding to a maximum extent of 0.5 per cent.

4. Use of modified starches — Modified food starches (derivative starches) may be used in confectionery,flavours, dairy products (where use of emulsifier/stabiliser is allowed in Appendix A and Chapter 5. glazes, icings,gravies, sauces, soups, coatings upto a maximum concentration of 0.5 per cent by weight.

Provided that modified food starches (derivative starches) may be used in snacks, frozen potato products,baked foods, and salad dressing/mayonnaise, upto a maximum concentration of 5 percent by weight.

5. Use of emulsifying and stabilising agents in flavouring agents - The emulsifying and stablising agentsmay be added to flavouring agents.

6. Use of emulsifying and stabilising agents in fruit products - The following emulsifying and stabilisingagents may be added to Fruit Products:

(a) Pectin

(b) Sodium alginate

Page 228: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 637

(c) Calcium alginate

(d) Alginic acid

(e) Propylene glycol alginate.

7. Use of emulsifying and stabilising agents in frozen desserts – The emulsifying and stabilizing agentsas defined under the Regulation 6.1.5 (1), may be added to frozen desserts.

8. Use of Hydroxypropyl Methyl Cellulose in various foods

Hydroxypropyl Methyl Cellulose may be used in the following food products, not exceeding the maximumlevels mentioned in column 3 of the table given below :

Sl No Article of food Maximum level

(i) Non dairy whip topping 2.0%

(ii) Snacks, savouries, luncheon meat and poultry products, instant mixes such as 1.0%idli mix, dosa mix, upma mix, pongal mix, puliyogore mix, gulab jamun mix,jalebi mix, vada mix, etc, salad dressing/mayonnaise, mixes for gravies,ice cream, frozen desserts, puddings and custards

(iii) Mixes for dairy based drinks 0.5%

(9) Use of Xanthan gum.-Xanthan gum may be used in the following products, namely :—

Non dairy whip toppings maximum 0.5% by weight

Bakery mixes maximum 0.5% by weight

(10) use of acid treated starch in sugar confectionery: Acid treated starch may be used in sugar confectioneryon GMP basis

Regulation 6.1.6: Anticaking Agents

(1) Restriction on use of anticaking agents.

No anticaking agents shall be used in any food except where the use of anticaking agents is specificallypermitted.

Provided that table salt, onion powder, garlic powder, fruit powder and soup powder may contain the followinganticaking agents in quantities not exceeding 2.0 per cent either singly or in combination namely :—

(a) carbonates of calcium and magnesium.

(b) phosphates of calcium and magnesium .

(c) silicates of calcium, magnesium, aluminium or sodium or silicon dioxide;

(d) myristates, palmitates or stearates of aluminium ammonium, calcium, potassium or sodium.

Provided that that calcium potassium or sodium ferrocyanide may be used as crystal modifiers and anti-cakingagent in common salt, iodised salt and iron fortified salt in quantity not exceeding 10 mg/kg singly or in combinationexpressed as ferrocyanide.

Regulation 6.1.7: Antifoaming agents in edible oils and fats.

(1) Dimethyl Polysiloxane, food grade, may be used as an antifoaming agent in edible oils and fats for deep fatfrying upto a maximum limit of 10 parts per million.

Provided that mono and diglycerides of fatty acids of edible oil may be used as antifoaming agent in jam, jelliesand marmalade

Explanation-For the purpose of this Regulation,”Anti foaming agent” means substance which retardsdeteriorative changes and foaming height during heating.

Page 229: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

638 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 6.1.8: Use of release agents in confectionery.

Spreadasil silicon spray (Dimethyl Polysiloxane) if used, as release agent in confectionery, shall not exceed 10ppm of the finished product.

Regulation 6.1.9 : Flavouring Agents And Related Substances

(1) Flavouring agents:

Flavouring agents include flavour substances, flavour extracts or flavour preparations, which are capableof imparting flavouring properties, namely taste or odour or both to food. Flavouring agents may be offollowing three types :—

(i) Natural Flavours and Natural Flavouring substances means flavour preparations and singlesubstance respectively, acceptable for human consumption, obtained exclusively by physical processesfrom vegetables, for human consumption

(ii) Nature-Identical Flavouring Substances means substances chemically isolated from aromaticraw materials or obtained synthetically; they are chemically identical to substances present in naturalproducts intended for human consumption, either processed or not.

(iii) Artificial Flavouring Substances means those substances which have not been identified innatural products intended for human consumption either processed or not;

(2) Use of anti-oxidants, emulsifying and stabilising agents and food preservatives in flavour.

The flavouring agents may contain permitted anti-oxidants, emulsifying and stabilising agents andfood preservatives.

(3) Use of Anticaking agent in flavours: Synthetic Amorphous Silicon Dioxide may be used in powder flavouringsubstances to a maximum level of 2 percent

(4) Restriction on use of flavouring agents :—

The use of the following flavouring agents are prohibited in any article of food, namely :—

(i) Coumarin and dihydrocoumarin;

(ii) Tonkabean (Dipteryl odorat);

(iii) â-asarone and cinamyl anthracilate”.

(iv) Estragole

(v) Ethyl Methyl Ketone

(vi) Ethyl-3-Phenylglycidate

(vii) Eugenyl methyl ether

(viii) Methyl â napthyl Ketone

(ix) P.Propylanisole

(x) Saffrole and Isosaffrole

(xi) Thujone and Isothujone á & â thujone.

(5) Solvent in flavour.

Diethylene Glycol and Monoethylether shall not be used as solvent in flavours.

Regulation 6.1.10: Use of Flavour Enhancers

(1) Monosodium Glutamate —

Monosodium Glutamate may be added to foods as per the provisions contained in Appendix A, subjectto Good Manufacturing Practices (GMP) level and under proper label declaration as provided in Regulation

Page 230: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 639

4.4.5 (18) of these Regulations. It shall not be added to any food for use by infant below twelve months andin the following foods:—

List of foods where Monosodium Glutamate is not allowed

(i) Milk and Milk Products including Buttermilk.

(ii) Fermented and renneted milk products (plain) excluding dairy based drink.

(iii) Pasteurized cream.

(iv) Sterilised, UHT, whipping or whipped and reduced fat creams.

(v) Fats and Oils, Foodgrains, Pulses, Oil seeds and grounded/ powdered foodgrains.

(vi) Butter and concentrated butter.

(vii) Fresh fruit.

(viii) Surface treated fruit.

(ix) Peeled or cut fruit.

(x) Fresh vegetables, Surface treated fruit, Peeled or cut fruits.

(xi) Frozen vegetables.

(xii) Whole, broken or flaked grains, including rice.

(xiii) Flours of cereals, pulses and starches.

(xiv) Pastas and noodles (only dried products).

(xv) Fresh meat, poultry and game, whole pieces or cuts or comminuted.

(xvi) Fresh fish and fish products, including mollusks, crustaceans and echinoderms.

(xvii) Processed fish and fish products, including mollusks, crustaceans and echinoderms.

(xviii) Fresh eggs, Liquid egg products, Frozen egg products.

(xix) White and semi-white sugar (sucrose and sacharose, fructose, glucose (dextrose), xylose,sugar solutions and syrups, also (partially) inverted sugars, including molasses, treacleand sugar toppings.

(xx) Other sugars and syrups (e.g. brown sugar and maple syrup).

(xxi) Honey

(xxii) Salt

(xxiii) Herbs, spices and condiments, seasoning (including salt substitutes) except seasoning forNoodles and Pastas, meat tenderizers, onion salt, garlic salt, oriental seasoning mix, toppingto sprinkle on rice, fermented soyabean paste, Yeast.

(xxiv) Infant food and Infant milk substitute including infant formulae and follow-on formulate.

(xxv) Foods for young children (weaning foods).

(xxvi) Natural Minerals water and Packaged Drinking water.

(xxvii) Concentrates (liquid and solid) for fruit juices.

(xxviii) Canned or bottled (pasteurized) fruit nectar.

(xxix) Concentrates (liquid and solid) for fruit juices.

(xxx) Canned or Bottled (pasteurized) fruit nectar.

(xxxi) Coffee and coffee substitutes, tea, herbal infusions, and other cereal beveragesexcluding cocoa.

Page 231: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

640 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(xxxii) Wines.

(xxxiii) Margarine

(xxxiv) Fat Spread

(xxxv) Fruits and Vegetables products except those where Monosodium Glutamate is permittedunder Appendix A of these Regulations.

(xxxvi) Carbonated Water

(xxxvii) Baking Powder

(xxxviii) Arrowroot

(xxxix) Sago

(xl) Plantation Sugar, Jaggery and Bura.

(xli) Ice-Candies.

(xlii) Ice cream and Frozen desserts.

(xliii) Cocoa Butter

(xliv) Saccharine

(xlv) Malted Milk Food and Milk based foods

(xlvi) Bread

(xlvii) Vinegar

(xlviii) Sugar Confectionery, Toffee, Lozenges.

(xlix) Chocolate

(l) Pan Masala

(li) Alcoholic Beverages.

Regulation 6.1.11 : Sequestering And Buffering Agents (Acids, Bases, And Salts)

(i) “sequestering agents” means substances which prevent adverse effect of metals catalysing the oxidativebreak-down of foods forming chelates; thus inhibiting decolourisation, off taste and rancidity;

(ii) “Buffering agents” means materials used to counter acidic and alkaline changes during storage or processingsteps, thus improving the flavour and increasing the stability of foods;

(1) Restrictions on the use of sequestering and buffering agents.

Unless otherwise provided in these regulations the sequestering and buffering agents specified in column (1)of the Table below, may be used in the groups of food specified in the corresponding entry in column (2) of the saidTable, in concentration not exceeding the proportions specified in the corresponding entry in column (3) of the saidTable :

TABLE

Sl. Name of sequestering And Groups of food Maximum levelNo. buffering agents of use (parts

per Million)(ppm) (mg./kg.)

(1) (2) (3) (4)

1. Acetic Acid (i) Acidulant, buffering and neutralizing agents Limited byin beverages soft drinks G.M.P.

(ii) in canned baby foods 5,000

Page 232: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 641

(1) (2) (3) (4)

2. Adipic acid Salt substitute and dietary food 250

3. Calcium Gluconate In confections 2,500

4. Calcium Carbonate As a neutralizer in number of foods 10,000

5. Calcium oxide As a neutralizer in specified dairy product 2,500

6. Citric acid malic acid Carbonated beverage and as an acidulant in Limited Bymiscellaneous foods G.M.P.

7. DL Lactic Acid (food grade) As acidulant in miscellaneous foods Limited ByG.M.P.

(8) L(+) Lactic Acid (food grade) As acidulant in miscellaneous foods Limited byGMP

9. Phosphoric acid Beverages, soft drinks 600

10. Polyphosphate containing less (a) Processed cheese, bread 40,000

than 6 Phosphate moieties (b) Milk Preparations 4,000

(c) Cake Mixes 10,000

(d) Protein foods 4,000

11. L (+) Tartaric acid Acidulants 600

12. Calcium Disodium, Ethylene, (i) Emulsions containing refined vegetable oils, 50Diamine tetra acetate eggs, vinegar, salt, sugar and spices;

(ii) Salad dressing;

(iii) Sandwich spread or fat Spread

13. Fumaric acid As acidulant in Miscellaneous foods 3000ppm

NOTE :- DL Lactic acid and L(+) Tartaric acid shall not be added to any food meant for children below 12months (The lactic acid shall also conform to the specification laid down by the Indian Standards Institution.)

Regulation 6.1.12: Use of Glycerol Esters of Wood Rosins (Ester Gum)—

The maximum limit of glycerol esters of wood resins(ester gum) when used in flavour emulsions, soft drinkconcentrate and carbonated water shall not exceed 100 P.P.M. of the final beverage for consumption.

Regulation 6.1.13: Use of Sucrose Acetate Isobutyrate — The maximum concentration of Sucrose Acetate Isobutyratewhen used in non-alcoholic beverages as a clouding agent shall not exceed 300 ppm;

Regulation 6.1.14: Use of Lactulose Syrup in foods:

(1) Lactulose syrup may be used in special milk based infant food formulations, which is to be taken undermedical advice upto a maximum level of 0.5 per cent of final food subject to label declaration.

(2) Lactulose syrup may be used in bakery products upto 0.5 per cent maximum by weight.

Regulation 6.1.15: Use of Dimethyl Dicarbonate:

Dimethyl Dicarbinate may be used in fruit drinks, ready to drink tea beverages, isotonic/sports drinks andflavoured water upto 250 mg/litre subject to a maximum methanol content in final product as 200 mg/litre

Page 233: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

642 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Regulation 6.1.16: Other substances to be used in Specified limits

The use of substances specified in column (1) in the food mentioned in column (2) of the Table given belowshall not exceed the limit specified in column (3) of the said table, namely :—

TABLE

S.No. Substances Food Maximum levelof use (ppm)mg/kg

1 2 3 4

1. Ammonium Carbonate Baked foods confections 5,000

2. Ammonium bicarbonate -do- GMP

3. Baking powder Baked foods GMP

4. Ammonium Phosphate Monobasic Bread 2,500

5. Ammonium persulphate -do- 2,500

6. Calcium Phosphate -do- 2,500

7. Calcium Carbonate -do- 5,000

8. Potassium Bromate and /or -do- 50Potassium Iodate

9. Ammonium Chloride -do- 500

10. Fungal Alpha-amylase -do- 100

11. Sodium Stearoyl-2 Lactylate or -do- 5,000Calcium Stearoyl-2 Lactylate(Singly or in combination)

12. L-Cystein Mono Hydrochloride -do- 90

13. Benzoyl Peroxide Flour for bakery 40

14. Potassium bromate -do- 20

15. Ascorbic acid -do- 200

16. Gluconodelta Lactone Cured meat or meat products 5,000

17. Chlorine Flour for bakery 2,000

18. Ascorbic acid/Iso Ascorbic acid Corned beef, Luncheon Meat, Cooked Ham, 500and its salts singly or in combination Chopped Meat, Canned Chicken, Canned

Muttonand Goat Meat.

(19) Phosphates (Naturally present Luncheon Meat,Cooked Ham, Chopped Meat. 8000and added) expressed as P2O5

Regulation 6.1.17: Carry Over Of Food Additives

For the purpose of the standards specified in Chapter 5 the “Carry Over” principle applies to the presence ofadditives such as colours, flavouring agents, anti-oxidants anti-caking agents, emulsifying and stabilising agents,and preservatives in food, as a result of the use of raw material or other ingredients in which these additives wereused. The presence of contaminants is not covered by this purpose.

The presence of an additive in food through the application of the carry over principle is admissible in generalunless otherwise specifically prohibited in the regulations provided the total additive including the carry overthrough the raw material or other ingredients does not exceed the maximum amount so permitted.

Page 234: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 643

Part 6.2: Standards of Additives

Regulation 6.2.1 Food Colours: Standards of various Food Colours with characteristics are specified in the tablebelow:

(1) Tartrazine

Common Name Tartrazine

Synonyms FD and C Yellow No.5, E.E.C. Serial No.E 102, L-Gebb 2, C.I.Food Yellow 4.

Colour of the 0.1 Per cent(M/V) solution Yellowin distilled water.

Colour Index Number (1975) No 19140

Class Monoazo.

Chemical Name Trisodium salt of 5-hydroxy-1-p- sulphopheny1-4-(p-sulphophenylazo) pyrazol-3-carboxylic acid.

Empirical formula C16 H9 N4 O9 S2 Na3

Molecular Weight 534.37

Solubility Soluble in water. Sparingly soluble in Ethanol.

General Requirements

The material shall conform to the requirements prescribed in Table below:—

TABLE

Sl. No. Characteristic Requirement

1. Total dye content, corrected for Sample dried at105±1oC for 2 hours, per cent by mass, Min. 87

2. Loss on drying at 135oC and Chlorides and Sulphates expressed as sodium salt, 13percent by mass, Max.

3. Water insoluble matter, percent by mass, Max. 0.2

4. Combined ether extracts, percent by mass. Max. 0.2

5. Subsidiary dyes, percent by mass, Max. 1.0

6. Dye intermediates, percent by mass, Max. 0.5

7. Lead, mg/kg, Max. 10

8. Arsenic, mg/kg, Max. 3

9. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds,aromatic hydrocarbons, and cyanides.;

(2) Sunset Yellow

Comm

Common Name Sunset Yellow

Synonyms FD and C Yellow No.6, JanusOrange S, C.l. Food Yelow 3, -Orange2, Janune soil, EEC Serial No.E.10

Colour of the 0.1 Percent (M/V) solution in Orangedistilled water

Page 235: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

644 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Colour Index Number (1975) No 15985

Class (1975) Monoazo

Chemical Name Disodium salt of 1.(4-sulphophenylazo) 2-napthol-6-sulphonic acid

Empirical formula C10H10N2O7S2NA2

Molecular Weight 452.37

Solubility Soluble in water. Sparingly soluble in Ethanol

General Requirements

The material shall conform to the requirements prescribed in Table below:—

TABLE

Sl. No. Requirements for Sunset Yellow, FCF Characteristic Requirement

1. Total dye content, corrected for Sample dried at105±1oC for 2 hours, per cent by mass, Min. 87

2 Loss on drying at 135oC, percent by mass and Chlorides and Sulphates expressed as Max 13sodium salt, percent by mass,

3. Water insoluble matter, percent by mass, Max. 0.2

4. Combined ether extracts, percent by mass. Max. 0.2

5. Subsidiary dyes, (lower sulphonated dyes includingtraces of orange II) percent by mass, Max. 3.0

6. Dye intermediates, percent by mass, Max. 0.5

7. Lead, mg/kg, Max. 10

8. Arsenic, mg/kg, Max. 3

9. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds,aromatic hydrocarbons, and cyanides;

(3) Erythrosine

distilled water

Common Name Erythrosine

Synonyms FD and C Red No.3 C.l. Food Red 14, LB-Rot-I

Colour of the 0.1 Percent (M/V) solution in Reddistilled water

Colour Index Number (1975) No 45430

Class Xanthene

Chemical Name Disodium or dipotassium salt of 2',4', 5', 7', tetraiodo-fluerescein

Empirical formula C20 H6 O5 I4 Na2

Molecular Weight 879.87 (Disodium Salt)

Solubility Soluble in water. Sparingly soluble in Ethanol

Page 236: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 645

General Requirements

The material shall conform to the requirements prescribed in Table below:—

TABLE

Sl. No. Requirements for Erythrosine Characteristic Requirement

1. Total dye content, corrected for Sample dried at105o±1oC for 2 hours, per cent by mass, Min. 87

2. Loss on drying at 135oC percent by mass and Chlorides andSulphates expressed as sodiumsalt percent by mass, Max. 13

3. Water insoluble matter, percent by mass, Max. 0.2

4. Ether extractable matter,(alkaline), percent by mass. Max. 0.2

5. Inorganic Iodide, percent by mass as sodium iodide, Max. 0.1

6. Subsidiary colouring matters except flourescein,percent by mass, Max. 4

7. Fluorescein, mg/kg, Max. 20

8. Organic compounds other than colouring matter 0.2

(a) Tri-iodoresorcinol, percent by mass, Max. 0.2

(b) 2.(2,4-dihydroxy-3,5-di-iodobenzoyl) benzoic acid,percent by mass, Max. 0.2

9. Lead, mg/kg, Max. 10

10. Arsenic, mg/kg, Max. 3

11. Zinc, mg/kg, Max. 50

12. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitrocompounds, aromatic hydrocarbons, and cyanides.

distilled water

Common Name Indigo carmine

Synonyms Indigotine, FD and C Blue No.2, Cl Food Blue 1, EEC SerialNo. E132 L-Blue 2

Colour of the 0.1 Percent (M/V) solution in Bluedistilled water

Colour Index Number (1975) No 73015

Class Indigoid

Chemical Name Disodium Salt of indigotine-5, 5'-Disulphonic acid

Empirical formula C16H8N2 O8 S2 Na2

Molecular Weight 466.36

Solubility Soluble in water. Sparingly soluble in Ethanol

Page 237: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

646 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

General Requirements

The material shall conform to the requirements prescribed in Table below:—

TABLE Requirement for Indigo Carmine

Sl. No. Characteristic Requirement

1. Total dye content, corrected for Sample dried at 105±1oC for 2 hours, per cent by mass, Min. 852. Loss on drying at 135oC, percent by mass and Chlorides and Sulphates expressed as sodium salt,

percent by mass, Max. 153. Water insoluble matter, percent by mass, Max. 0.24. Combined ether extracts, percent by mass. Max. 0.25. Subsidiary dyes, percent by mass, Max. 1.06. Isatin Sulphonic acid, percent by mass, Max. 0.57. Lead, mg/kg, Max. 108. Arsenic, mg/kg, Max. 39. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitrocompounds, aromatic hydrocarbons, and cyanides.

(5) - â-Carotene.

â-Carotene is obtained as dark violed hexagonal prisms when crystallised from benzene methanolsolution; or as red rhombic, almost quardratic plates, from petroleum ether.

Synonyms C.I. natural yellow 26Colour Index Number (1975) No.75130Class CarotenoidsChemical Name all trans â-CaroteneEmpirical formula C40 H56Molecular Weight 536.89Melting Point 183oC ± 1oC

Solubility.- Soluble in carbon disulphide, benzene and chloroform, moderately soluble in normal hexane,cyclohexane, ether, petroleum ether and oils; practically insoluble in methanol and ethanol; insoluble in water.

Spectrophotometric Requirement.-The wavelengths of absorption maxima of all trans â-Carotene incyclohexane (0.2 mg per 100 ml. approximately) and in-1cm cell shall be 456 mμ to 484 mμ region. There shall beno cis-peak in the 330 mμ to 355 mμ region.

A solution of B-carotene in chloroform on addition of antimony trichloride solution shall give a darkblue colour having maximum absorption at a wavelength of 590 mμ.

Colour Reaction- When 2ml. of concentrated sulphuric acid is added to 2m. of 0.2 per cent solution ofâ-Carotene in chloroform, the acid layer shall turn blue.

The material shall have a minimum purity of 96.0 per cent.

Maximum limit of metallic impurities shall be:—

Arsenic (as As) 3 p.p.m.Lead (as Pb) 10 p.p.m.Heavy metal 40 p.p.m.And shall also meet the following requirements:—

(i) Subsidiary colouring matter, percent by weight, Max 3(ii) Sulphated ash, percent of total colouring matters, Max 0.1

Page 238: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 647

(6) Chlorophyll:

Chlorophyll, the green pigment of plants, is extracted and widely used as a colouring matter for variousfood items.

Synonyms C.I. Natural Green 3; Lebensmittel Green No.1

Colour Index Number (1956) No.75810

Colour Index Number (1924) No. 12499

Color Green

Class Phorbin (dihydrophorphin)

Chemical Name Chlorophyll a - magnesium complex of 1,3,5,8-tetramethyl 4-ethyl-2-vinyl-9-keto-10 carbomethoxy phorbinphytyl-7-propionate.Chlorophyll b magnesium complex 1,5,8 trimethyl-3-formyl-4-ethyl-2- vinyl-9-keto-10 carbomethoxyphorbinphytyl-7-propionate

Empirical formula Chlorophyll a - C55H72O5N4MgChlorophyll b- C55H70O6N4Mg

Molecular Weight Chlorophyll a- 893.54Chlorophyll b - 907.52

General- The material shall be an intensely dark green, aqueous, ethanolic, or oily solution of chlorophylldegradation products. It shall be soluble in ethanol, ether, chloroform and benzene. It shall be insoluble in water.

Identification test- A solution of chlorophyll in ethanol shall be blue with deep red flourescence.

Brown-phase Reaction-When green ether or petroleum ether solution of chlorophyll is treated with a smallquantity of a 10 per cent solution of potassium hydroxide in methanol, the colour shall become brown quicklyreturning to green.

Note.- This test is applicable only when chlorophyll has not been treated with alkalies.

Maximum limits for metallic impurities shall be:—

Arsenic (as As) 3 ppm

Lead (as Pb) 10 ppm

Copper (as Cu) 30 ppm

Zinc (as Zn) 50 ppm

The material shall also conform to the following requirements:—

Chlorophyll – Magnesium Complex

Sl. No Characteristics Requirements

1 Total combined phaeophytines and their magnesium complexes, percent by weight, max. 10

2 Residual solvents, mg/kg, Max. Acetone, methanol, ethanol, propan-2-ol, hexane 50

Dichloromethane 10

(7) Caramel

Caramel shall be prepared from the food grade carbohydrates or their combinations in the presence offood grade acids, alkalis or salts. It shall be of four types, namely:—

Type-I- Plain Caramel-It shall be prepared by heating carbohydrates with or without acids or alkalis, ortheir salts. No. ammonium or sulphite compounds are used.

Type-II-Caustic sulphite caramel- It shall be prepared by heating carbohydrates with or without acids oralkalis or their salt in the presence of sulphite compounds; no ammonium compounds are used.

Page 239: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

648 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Type - III - Ammonia Process Caramel- It shall be prepared by heating carbohydrates with or withoutacids or alkalis or their salts in the presence of ammonium compounds; no sulphites are used.

Type-IV- Ammonia Sulphite Caramel- It shall be prepared by heating carbohydrates with or withoutacids or alkalis or their salts in the presence of both sulphite and ammonium compounds.

Raw Materials

(1) Carbohydrates - Caramel shall be prepared from the following carbohydrates or their mixtures:—

Sucrose, glucose, fructose, invert sugar, lactose, malt syrup, molasses, starch hydrolysates and fractionsthere of and/or polymer thereof.

(2) Acids and alkalis- The acids used are sulphuric acid, phosphoric acid, acetic acid, or citric acid andthe alkalis used are sodium, potassium or calcium hydroxide or mixture thereof.

Where the ammonium compounds are used, they are one or more of the following:—

Ammonium hydroxide

Ammonium Carbonate and Bicarbonate

Ammonium phosphate

Ammonium sulphate

Ammonium sulphite, Bisulphite, Metasulphite

Where the sulphite compounds are used, they are one or more of the following:—

Sulphurous acid, Potassium, Sodium or ammonium Sulphite or Bisulphite.

It shall be a dark brown to black liquid or solid materials having the characteristic odour of burntsugar and a pleasant, bitter taste. Its solution, when spread in a thin layer on a glass plate should appearhomogeneous, transparent and have reddish-brown colour. It shall be miscible with water. It shall befree from any other extraneous colouring matter. It may contain permitted emulsifying and stabilisingagents.

It shall conform to the requirements prescribed in Table 1 below. All requirements shall be onsolids basis, except metallic impurities.

Table 1 - Routine Test Requirements For Caramel

Sl. Characteristic Type I Type II Type III Type IVNo. Plain CausticSulphite AmmoniaProcess Sulphite

Ammonia

1. Solid content,per cent by mass 62-77 65-72 53-83 40-75

2. Colour intensity,per cent by mass 0.01-0.12 0.06-0.10 0.08-0.36 0.10-0.60

3. Ammonical nitrogenper cent by mass, max. 0.01 0.01 0.4 0.5

4. 4-Methylimidazole - - Max. 300mg/kg & Max.1000mg/kgMax. 200mg/kg &Max.250mg/kgon equivalent on equivalentcolour basis colour basis

5. Lead (as Pb), mg/kg,Max. 5 5 5 5

6. Arsenic(as AS) mg/kg. 3 3 3 3

Note: Requirement of ammoniacal nitrogen is based on a product colour having a minimum colour intensity prescribedat Sl. No. (2) proportionately higher values of ammoniacal nitrogen apply for products of higher colour intensity.

Page 240: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 649

Type TestThe material shall also conform to the requirements prescribed in Table 2 below.All requirements shall be on solid basis except metallic impurities.

Table 2 - Type Test Requirements For Caramel

Sl. Characteristic Type I Type II Type III Type IVNo. Plain CausticSulphite AmmoniaProcess Sulphite

Ammonia

1. Total sulphurPer cent by mass. Max.03 1.3-2.5 Max.0.3 1.4-10.02. Sulphur dioxide(as SO2) — Max. 0.2% — Max.0.5%3. Total nitrogen,Per cent by mass Max.0.1 Max.0.2 1.3-6.8 0.5-7.54. Heavy metals mg/kg (Max.) 25 25 25 255. 2-Acetyl-4- tetraphydroxy butylimidazole — — Max.40 mg/kg & —

(THI) Max. 25 mg/kg onan equivalentcolour basis

6. Mercury (as Hg) mg/kg, Max. 0.1 0.1 0.1 0.17. Copper (as Cu) mg/kg, Max. 20 20 20 20

The material shall be filled in amber coloured glass or high density polythylene containers or any otherwell closed suitable containers with as little air space as possible. The containers shall be such as to precludecontamination of the contents with metals or other impurities.

(8) Annatto

Class Carotenoids

Code Number Cl (1975) No. 75120', Cl (1975) Natural Orange 4 EEC No.E-160 b

Chemical Name Annatto extract in oil contains several coloured components, themajor single one being bixin which may be present in both Cisand Transforms. Thermal degradation products of bixin may alsobe present

Solubility Water soluble annatto contains norbixin, the hydrolysis productof bixin, in the form of sodium or potassium salt, as the majorcolouring principle. Both cis and trans forms may be present

Chemical Formula Bixin C25 H30 O4Norbixin C24 H28 O4

Molecular Weight Bixin 394.50Norbixin 380.48

The material shall be of the following two types:

(a) Solution in oil for use in butter and other food products, and

(b) Solution in water for use in cheese and other food products.

General

The material shall be derived only from the plant Bixa orellana L. and shall not contain any extraneouscolouring matter. It shall be processed, packed, stored and distributed under hygienic conditions in licensedpremises.

(1) Solution of Annatto Colour in Oil for Use in Butter and Other Food Products:—

Page 241: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

650 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Annatto extract in oil, as solution or suspension, is prepared by extraction of the outer coating ofseeds with vegetable oils. In the preparation of the solution of annatto colour in oil, only the ediblevegetable oils shall be used, either singly or in a mixture.

The solution of annatto colour in oils shall be clear and shall remain so on storage in suitablecontainers at 15oC except for a slight deposit of stearine or shall be in the form of a suspension. Thesuspension on dilution with hot oil to bring the bixin content to 0.24 per cent shall be a clear solution.

Colour

The colour of solution in amyl acetate at a dilution of 1:1000 (m/v) when measured in a LovibondTintometer with a 1 cm Cell Spectrophotometrically/Calorimeterically shall be not less than the following:

Yellow units 5.0

Red units 0.4

or be not less than the colour of the following inorganic solution at a liquid depth of one centimeterwhich may be employed for matching the stated dilution in a plunger type colorimeter using incident lightclosely approximating the normal day light:

Potassium Bichromate 0.320 g

Cobalt ammonium sulphate 2.02 g

(CoSO4 (NH4)2 SO4 6H2O)Sulphuric acid, Sp-gr 1.84 2ml

Distilled water To make solution to one litre

These reagents shall be of the analytical reagent grade. Although the solution retains its tinctorial valuefor a considerable time, after prolonged storage, its optical clarity shall be examined before use, to ensure thatno alteration has taken place.

Note 1 - Diluted solution of annatto colour in amyl acetate is not stable in colour quality, particularly ifexposed to light, and measurement shall be carried out on the diluted solution without undue delay.

(ii) Solution of Annatto Colour in Water for use in Cheese and Other Food Products:

Water soluble annatto colour is prepared by extraction of the outer coating of the seeds with aqueousalkali (sodium or potassium hydroxide). In the preparation of the solution, potable water shall be used. A littlequantity (0.5 to 3 per cent) of alkali may be added.

The solution shall be clear and shall remain so on storage in suitable containers at a temperature of 15oC.

Colour

The colour of the solution in 0.1 N sodium hydroxide or potassium hydroxide at a dilution of 1:1000 (m/v) measured in a 1-cm shall be the same as that specified in (i) above.

The material shall conform to the requirements prescribed in Table below:

TABLE

Sl. No. Requirement for Annatto Characteristic Requirement

1. Carotenoid

(a) Annatto extract in oil, expressed as bixin, per cent by mass, Min. 0.24

(b) Water-soluble annatto, expressed as norbixin, percent by mass, Min. 0.24

2. Arsenic, mg/kg, Max. 3

3. Lead, mg/kg, Max. 10

4. Copper, mg/kg, Max. 30

5. Heavy metal, mg/kg, Max. 40

Page 242: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 651

(9) Riboflavin

Riboflavin is a yellow to orange-yellow crystalline powder. Melting point about 280oC with decomposition.

Solubility-slightly soluble in water, more soluble in saline solution and in a 10 per cent (w/v) solution ofurea, sparingly soluble in alcohol, practically insoluble in chloroform and in solvent ether and soluble in dilutesolution of alkali hydroxides.

Synonyms Vitamin B2, Lactoflavin and Lactroflavine

Color Yellow to orange-yellow

Class Isoalloxazine

Chemical Name 6.7-dimethyl-9-(d-1-ribityl)- isoalloxazine

Empirical formula C17H20N4O6

Molecular Weight 376.38

Identification.-A solution of 1 mg of Riboflavin in 100 ml water is pale greenish yellow in transmittedlight, and has an intense yellowish green flourescence which disappears on the addition of sodium dithioniteand mineral acids or alkalies.

Spectrophotometry-Absorption maxima of aqueous solution shall be at 220 to 225, 266, 371 and 444 mu.

Specific Rotation-It shall be determined in a 0.5 per cent w/v solution in a mixture of 1.5 ml of 0.1 Nalcoholic solution of potassium hydroxide (free from carbonate) and sufficient freshly boiled and cooled waterto produce 10 ml. The specific rotation, when calculated with reference to the substance dried to constantweight in the dark at 105oC, shall be, 122oC.

The material shall have minimum purity of 97.0 per cent.

Maximum limit of metallic impurities shall be:—

Arsenic (as As) 5 p.p.m.

Lead (as Pb) 20 p.p.m.

(10) Ponceau 4R

Commo

Common Name Ponceau 4R

Synonyms Cl Food Red 7, L-Rot No.4, Coccine Nouvelle, CochinealRed A; EEC Serial No.E 124

Colour of the 0.1 Percent (M/V) solution in Reddistilled water

Colour Index Number (1975) No. 16255

Class Monoazo

Chemical Name Trisodium salt of 1-(4-sulpho-1-naphtylazo) naphthol-6, 8-disulphonic acid

Empirical formula C20 H11 N2 O10 S3 Na2

Molecular Weight 604.5

Solubility Soluble in water. Sparingly soluble inEthanol

Page 243: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

652 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

The material shall conform to the requirements prescribed in Table below:—

TABLE

Sl. No. Requirements for Ponceau 4R Characteristic Requirement

1. Total dye content, corrected for Sample driedat 105±1oC for 2 hours, per cent by mass, Min. 852 Loss on drying at 135oC, percent by mass, Max. and Chlorides and Sulphates expressed as

sodium salt, per cent by mass, Max 183. Water insoluble matter, percent by mass, Max. 0.24. Combined ether extracts, percent by mass. Max. 0.25. Subsidiary dyes, percent by mass, Max. 1.06. Dye intermediates, per cent by mass, Max. 0.57. Lead, mg/kg, Max. 108. Arsenic, mg/kg, Max. 39. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, selenium and chromium in any form; aromatic amines, aromatic nitrocompounds, aromatic hydrocarbons, and cyanides.;

(11) Carmoisine

Common Name CarmoisineSynonyms Azorubine, C.I. Food Red 3, EEC. Serial No.E 122Colour of the 0.1 Percent (M/V) solution in Reddistilled waterColour Index Number (1975) No.14720Class MonoazoChemical Name Disodium salt of 2-(4-sulpho-1-naphthylazo)-1-hydroxy-

naphthalene-4-sulphonic acidEmpirical formula C20H12N2O7S2Na2Molecular Weight 502. 44

General Requirements: The material shall be free from mercury, selenium and chromium in any form, aromatic amines,aromatic nitro compounds, aromatic hydrocarbons and cyanides.

Carmoisine shall also comply with requirements prescribed in Table below:—

TABLE

Sl. No. Requirements for Carmoisine Characteristic Requirement

1. Total dye content, corrected for Sample driedat 105±1oC for 2 hours, per cent by mass, Min. 87

2 Loss on drying at 135oC, percent by mass, Max. and Chlorides and Sulphates expressed assodium salt, per cent by mass, Max. 13

3. Water insoluble matter, percent by mass, Max. 0.2

4. Combined ether extracts, percent by mass. Max. 0.2

5. Subsidiary dyes, percent by mass, Max. 1.0

6. Dye intermediates, per cent by mass, Max. 0.5

7. Lead, mg/kg, Max. 10

8. Arsenic, mg/kg, Max. 3

9. Heavy metals, mg/kg, Max. 40

Page 244: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 653

(12) Synthetic Food Colour - Preparation And Mixtures.

Colour Preparation

A Preparation containing one or more of the permitted synthetic food colours conforming to theprescribed standard alongwith diluents and/or filler materials and meant to be used for imparting colourto food. It may contain permitted preservatives and stabilizers.

The colour preparation would be either in the form of a liquid or powder. Powder preparationsshall be reasonably free from lumps and any visible extraneous/foreign matter. Liquid preparations shallbe free from sediments.

Only the following diluents or filler materials shall be permitted to be used in colour preparationsconforming to the prescribed standards:—

(1) Potable water

(2) Edible common salt

(3) Sugar

(4) Dextrose Monohydrate

(5) Liqid glucose

(6) Sodium sulphate

(7) Tartaric acid

(8) Glycerine

(9) Propylene glycol

(10) Acetic acid, dilute

(11) Sorbitol

(12) Citric acid

(13) Sodium carbonate and sodium hydrogen carbonate

(14) Lactose

(15) Ammonium, sodium and potassium alginates

(16) Dextrins

(17) Ethyl acetate

(18) Starches

(19) Diethyl ether

(20) Ethanol

(21) Glycerol mono, di and tri acetate

(22) Edible oils and fats

(23) Isopropyl alcohol

(24) Bees wax

25. Sodium and ammonium hydroxide

26. Lactic acid

27. Carragenan and gum arabic

28. Gelatin

29. Pectin

Page 245: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

654 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Colour MixturesA mixture of two or more permitted synthetic food colour conforming to prescribed standards

without diluents and filler material and meant to be used for imparting colour to food.It may contain permitted preservatives and stabilizers.General Requirements-For Colour Preparation & Colour Mixture. The total Syn-thetic dye content,

per cent by mass (m/v) in the colour preparation or in the mixture shall be declared on the label of thecontainer. In powder preparations the declared value shall be on moisture free basis and in case of liquidpreparations on as in basis. The total dye content shall be within the tolerance limits given below on thedeclared value:(a) Liquid preparation +15 per cent

-5 per cent

(b) Solid preparations ±7.5 per cent

The limits of impurities shall be as prescribed in Table below:—

TABLE Limits for Impurities

1. Water insoluble matter, per cent by mass, Max. (on dry basis), Max. 1.02. Lead, (as Pb), mg/kg, Max. 103. Arsenic, (as As) mg/kg, Max. 3.04. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds,aromatic hydrocarbons, polycyclic aromatic hydrocarbon, 2-naphthyl aminobenzidine, amino-4-dipheyl (xenylamine) ortheir derivatives and cyanides.

The total coal tar dye content percent by mass (m/m) in colour preparation or in mixture shall be declared on the tableof the container. In powder preparation, the declared value shall be on moisture free basis and in case of liquid preparationon ‘as is basis’ and the total dye content shall within --_+ 15 percent of the declared value. Colour preparation and colourmixture shall also comply with the following requirements namely: —

Sl. No. Characteristics Requirements

1 Water insoluble matter, percent by mass Not more than 1.02 Arsenic as (As), parts per million Not more than 33 Lead as (Pb) parts per million Not more than 10

(13) Brilliant Blue Fcf

Brilliant Blue FCF is hydroscopic in nature and its shade changes with different pH. Suitable precautionsshould, therefore, be taken in packing the colour.

Colour Brilliant Blue FCF is described below, namely:—

Common Name Brilliant Blue FCFSynonyms C.l. Food Blue FD and C Blue No.1 Blue brilliant FCFColour BlueColour Index Number (1975) No.42900Class TriarymethaneChemical Name Disodium salt of alpha 4-(N- ethylbeta sulfobenzylamino)-

phenyl] alpha [4-(N-ethyl-3-Sulfonatobenzylimino]cyclohexa-2, 5-dienylidene] toluene-2-sulfonate

Empirical formula C17H14N2Ha2O9S2Molecular Weight 792.86

General requirements: The material shall conform to the requirement prescribed in Table Below, namely:—

Page 246: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 655

Table for Brilliant Blue FCF

S. No. Characteristics Requirements

(i) Total dye content, corrected for Sample dried at 105±1oC for 2 hours, percent by Mass, Minimum 85(ii) Loss on drying at 135oC, and Chlorides and Sulphates expressed as sodium salt, per cent by

Mass, Maximum 15(iii) Water insoluble matter, percent by Mass, Maximum 0.2(iv) Combined ether extracts, percent by Mass. Maximum 0.2(v) Subsidiary dyes, percent by Mass, Maximum 3(vi) Dye intermediates, percent by Mass, Max.

(a) O, sulpho-benzaldehyde, Maximum 1.5(b) N-N’ ethyl-benzyl-aniline-3-sulphonic acid, Maximum 0.3( c ) Leuco base, percent by Mass, Maximum 5

(vii) Heavy metals, (as Pb), mg/kg, Maximum 40Lead, mg/kg, Maximum 10Arsenic, mg/kg, Maximum 3Chromium, mg/kg, Maximum 50

Note:- The material shall be free from aromatic amines, aromatic nitro compounds, aromatic hydrocarbonsand cyanides.

(14) Fast Green FCF:Fast Green FCF is hydroscopic in nature and its shade changes with different pH. Suitable precautions

should, therefore, be taken in packing the colour.Fast Green FCF is described below, namely:—

Common Name Fast Green FCFSynonyms C.l. Food Green 3, FD and CGreen No.3, Vert Solide FCFClass TriarylmethaneColour GreenColour Index (1975) No.42053Chemical Name Disodium salt of 4-[4-(N-ethyl-p-sulfobenzylamino)-phenyl-

(4-hydroxy-2-sulphonumphenyl)-methylene]-(N-ethyl-N-p-sulphobenzyl 2, 5-cyclohexadienimine).

Empirical Formula C37 H34 O10 N2 S2 Na2Molecular Weight 808.86Requirements The material shall conform to the requirement prescribed in

Table below, namely:—

Table For Fast Green FCF

Sl. No. Characteristic Requirement

(i) Total dye content, corrected for Sample driedat 105±1oC for 2 hours, percent by mass, Minimum 85(ii) Loss on drying at 135oC, and, percent by Mass, Maximum and chlorides and Sulphates

expressed as sodium salt, percent by mass, Maximum 13(iii) Water insoluble matter, percent by Mass, Maximum 0.2(iv) Combined ether extracts, percent by Mass. Max 0.2(v) Subsidiary dyes, percent by mass, Maximum 1.0(vi) Organic compound other than colouring matter uncombined intermediates and products of

side reactions

Page 247: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

656 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. Characteristic Requirement(a) Sum of 2-, 3-, 4-formyl benzene sulphonic acid, sodium salts, percent by Mass, Maximum 0.5(b) Sum of 3- and 4-[ethyl (4-sulfophenyl) amino methyl benzene sulphonic acid, disodium salts,

Percent by Mass, Maximum 0.3(c) 2-formyl-5-hydroxybenzene sulphonic acid sodium salt, percent by Mass, Maximum 0.5(d) Leuco base, percent by Mass, Maximum 5.0(e) Unsulphonated primary aromatic amines (calculated as aniline), percent by Mass, Maximum 0.01

(vii) Lead, mg/kg, Maximum 10(viii) Arsenic, mg/kg, Maximum 3(ix) Chromium, mg/kg, Maximum 50(x) Mercury, mg/kg, Maximum Absent(xi) Heavy metals, mg/kg, Maximum 40Note:- The material shall be free from aromatic nitro compounds, aromatic hydrocarbons and cyanides

(15) Aluminium Lake of Sunset Yellow FCF Food Yellow No.5 Aluminium Lake is a fine orange yellow watersoluble, odourless powder. It is prepared by percipating Sunset Yellow FCF (conforming to specification under 10.02of Appendix C of these Regulations on to a substratum of Alumina.

Chemical Name - Sunset Yellow FCF Aluminium Lake -6, hydroxy-5 (4-sulfophenlyazo)-2Naphthalenesulphonic acid, Aluminium Lake.

Synonym - CI Pigment Yellow, 104, FD and C Yellow No. 6, Aluminium Lake (USA), Food Yellow No. 5Aluminium Lake (Japan).

(1) Sunset yellow dye used in preparation of lake colour shall conform to specifications laid down undertable 2 of these Regulations.

(2) Pure dye content of Aluminium Lake weight by weight not less than 17 percent(3) Substratum of Aluminium oxide not more than 83 percent.(4) Aluminium content in the lake weight by weight not more than 44 percent(5) Sodium chlorides and sulphates (as sodium salts) not more than 2.0 percent(6) Inorganic matter (HCl insoluble) not more than 0.5 percent(7) Lead (as Pb) not more than 10 ppm(8) Arsenic (as As) not more than 3 ppm

Alumina used in colour shall conform to following, namely:—

(a) Identity: Alumina (dried as aluminium hydroxide) is a white, odourless, tasteless, amorphouspowder consisting essentially of Aluminium hydroxide (Al2O3 x H2O).

(b) Specifications: Alumina (dried aluminium hydroxide) shall conform to the followingspecifications, namely:—

(i) Acidity or alkalinity Agitate 1 gm with 25ml of water and filter.The filtrate shall be neutral to litmus paper

(ii) Lead (as Pb) not more than 10 parts per million

(iii) Arsenic (as As) not more than 1 parts per million

(iv) Mercury (as Hg) not more than 1 parts per million

(v) Aluminium oxide (Al2O3) not less than 50 percent

Solubility: Lakes are insoluble in most solvents. They are also insoluble in water in pH range from 3.5-9.0 but outside this range and lake substrate tends to dissolve releasing the captive dye.

Page 248: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 657

CHAPTER 7PROHIBITION AND RESTRICTIONS ON SALES

Part 7.1 Sale of certain admixtures prohibited

Regulation 7.1.1

Notwithstanding the provisions of Part 4.7 no person shall either by himself or by any servant or agent sell–(1) cream which has not been prepared exclusively from milk or which contains less than 25 per cent. of

milk fat;(2) milk which contains any added water;(3) ghee which contains any added matter not exclusively derived from milk fat;(4) skimmed milk (fat abstracted) as milk;(5) a mixture of two or more edible oils as an edible oil;(6) vanaspati to which ghee or any other substance has been added;(7) turmeric containing any foreign substance;(8) mixture of coffee and any other substance except chicory;(9) dahi or curd not prepared from boiled, pasteurised or sterilized milk;(10) milk or a milk product specified in Chapter 5 containing a substance not found in milk, except as

provided in the regulations.

Provided that the Central Government or the Food Authority may, by notification in the Official Gazette exemptany preparations made of soluble extracts of coffee from the operation of this regulation.

Provided further that proprietary food articles relating to Regulation 7.1.1(8) shall be exempted from theoperation of this Regulation

Provided further that in respect of Regulation 7.1.1(5) a maximum tolerance limit of 10 red units in one cm.cell on Lovibond scale is permitted when the oil is tested for Halphen’s test without dilution, that is to say, byshaking 5 ml. of the sample with 5 ml. of sulphur solution (one per cent (w/v) solution of sulphur in carbon-di-sulphide mixed with equal volume of amyl alcohol), in a closed system (test tube 250 x 25cm.) heating in hot water(700C- 800°C) for a few minutes with occasional shaking until carbon-di-sulphide is boiled off and the sample stopsfoaming and then placing the tube on saturated brine bath, capable of being regulated at 1100C-1150C for 2.5 hours

Provided also that prohibition in Regulation 7.1.1 (5) shall remain inoperative in respect of admixture of anytwo edible vegetable oils as one edible vegetable oil, where –

(a) the proportion by weight of any vegetable oil used in the admixture is not less than 20 per cent. byweight; and

(b) the admixture of edible vegetable oils, is processed or packed and sold, by the Department of CivilSupplies, Government of India (Directorate of Vanaspati, Vegetable Oils and Fats) or by the agencies inpublic, private or Joint Sector authorized by the Department, or by the National Dairy Development Board orby the State Cooperative Oilseeds Growers Federation or Regional and District Cooperative Oilseeds GrowersUnion set up under National Dairy Development Board’s Oilseeds and Vegetable Oil Project or by the PublicSector undertakings of Central and State Governments, in sealed packages weighing not more than 15 litresunder Agmark Certification Mark compulsorily and bearing the label declaration as laid down in the Regulation4.4.2 (11) and

(c) the quality of each edible oil used in the admixture conforms to the relevant standard prescribed bythese regulations

Part 7.2: Restriction on use of certain ingredient:

Regulation 7.2.1:

No person in any State shall, with effect from such date as the state government concerned may by notificationin the official gazette specify in this behalf, sell or offer or expose for sale, or have in his possession for the purposeof sale, under any description or for use as an ingredient in the preparation of any article of food intended for sale:—

(a) Kesari gram (Lathyrus sativus) and its products.

Page 249: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

658 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(b) Kesari dal (Lathyrus sativus) and its products.

(c) Kesari dal flour (Lathyrus sativus) and its products.

(d) a mixture of Kesari gram (Lathyrus sativus) and Bengal-gram (Cicer arietinum) or any other gram.

(e) A mixture of Kesari dal (Lathyrus sativus) and Bengal-gram dal (Cicer arietinum) or any other dal.

(f) a mixture of Kesari dal (Lathyrus sativus) flour and Bengal-gram (Cicer arietinum) flour or any otherflour.

Explanation.—The equivalent of kesari gram in some of the Indian Languages are as follows:—

1. Assamese Khesari,Teora.

2. Bengali Khesari,Teora, Kassur,Batura.

3. Bihari Khesari,Teora,Kassur,Batura.

4. English Chikling vetch.

5. Gujarati Lang.

6. Hindi Khesari, Kessur, Kesari, Kassartiuri,Batura, Chapri, Dubia, Kansari, Kesori, Latri,Tinra, Tiuri, Kassor.

7. Kannada Laki Bele, Kessari Bele.

8. Malyalam Kesari, Lanki, Vattu.

9. Tamil Muku.

10. Marathi Lakheri, Batri, Lakhi, Lang, Mutra, Teora, Botroliki-dal, Lakh.

11. Oriya Khesra, Khesari, Khesari dal.

12. Persian Masang.

13. Punjabi Kisari, Chural, Karas, Karil, Kasa Kesari, Chapa.

14. Sanskrit Sandika, Triputi.

15. Sindhi Matter.

16. Telugu Lamka

Part 7.3 Prohibition and Restriction on sale of certain products

Regulation 7.3.1: Prohibition on sale of food articles coated with mineral oil: No person shall sell or offer orexpose for sale or have in his premises for the purpose of sale under any description, food articles which have beencoated with mineral oil, except where the addition of mineral oil is permitted in accordance with the standards laiddown in these Regulations and Chapter 5.

Regulation 7.3.2: Restriction on sale of Carbia Callosa and Honey dew.:Carbia Callosa and Honey dew shallbe sold only in sealed containers bearing Agmark seal.

Regulation 7.3.3: Food resembling but not pure honey not be marketed as honey: No person shall use theword ‘honey’ or any word, mark, illustration or device that suggests honey on the label or any package of, or in anyadvertisement for, any food that resembles honey but is not pure honey.

Regulation 7.3.4: Product not to contain any substance which may be injurious to health: Tobacco andnicotine shall not be used as ingredients in any food products.

Regulation 7.3.5: Prohibition of use of carbide gas in ripening of fruits: No person shall sell or offer orexpose for sale or have in his premises for the purpose of sale under any description, fruits which have beenartificially ripened by use of acetylene gas, commonly known as carbide gas.

Regulation 7.3.6: Sale of Fresh Fruits and Vegetables: The Fresh Fruits and Vegetables shall be free fromrotting and free from coating of waxes, mineral oil and colours.

Page 250: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 659

Provided that fresh fruits may be coated with bees wax (white and yellow) or carnauba wax or shellac wax atlevel not exceeding Good Manufacturing Practices under proper label declaration as provided in Regulation 4.4.5(44)

Regulation 7.3.7: Sale or use for sale of admixtures of ghee or butter prohibited: No person shall sell orhave in his possession for the purpose of sale or for use as an ingredient in the preparation of an article of food forsale a mixture of ghee or butter and any substance

(1) prepared in imitation of or as a substitute for ghee or butter, or

(2) consisting of or containing any oil or fat which does not conform to the definition of ghee;

Provided that where a mixture prohibited by this regulation is required for the preparation of an article of food,such mixture shall be made only at the time of the preparation of such article of food.

Regulation 7.3.8: Restriction on sale of ghee having less Reichert value than that specified for the areawhere such ghee is sold.

(1) The ghee having less Reichert value and a different standard for Butyro-refractometer reading at 400

C than that specified for the area in which it is imported for sale or storage shall not be sold or stored in thatarea except under the ‘AGMARK’ seal:

PROVIDED that such ghee may be (i) sold lose, after opening the ‘AGMARK’ sealed container, inquantities not exceeding two kilograms at a time, and (ii) used in the preparation of confectionery(including sweetmeats).

(2) A person selling:—

(i) such ghee in the manner specified in Regulation 7.3.8 (1) and

(ii) confectionery (including sweetmeats) in the preparation of which such ghee is used, shall givea declaration, in the Form B, Appendix C to the Food Safety Officer when a sample thereof is taken byhim for analysis under Section 47 of the Act and also to a purchaser desiring to have the sampleanalysed under Section 40 of the Act.

(iii) If on analysis such sample is found to be conforming to the standards of quality prescribedfor the area where it is alleged to have been produced, the ghee shall not be deemed to be adulteratedby reason only that it does not conform to the standards of quality prescribed for the area where it issold.

Regulation 7.3.9 : Restriction on sale of Til Oil produced in Tripura, Assam and West Bengal.

Til Oil (Sesame Oil) obtained from white sesame seeds, grown in Tripura, Assam and West Bengalhaving different standards than those specified for til oil shall be sold in sealed containers bearing Agmarklabel. Where this til oil is sold or offered for sale without bearing an Agmark label, the standard given for til oilshall apply.

Regulation 7.3.10: Special provisions relating to vegetable oil and fat

(1) No vegetable oil other than those specified under the list below or oil or fat of animal or mineral originshall be used in the manufacture of the products or shall otherwise be present therein;

List of vegetable oils Vanaspati shall be prepared from:

(a) Coconut oil

(b) Cottonseed oil

(c) Dhupa oil

(d) Groundnut oil

(e) Kokrum oil

(f) Linseed oil

(g) Mahua oil

Page 251: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

660 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(h) Maize (Corn) oil

(i) Mango kernel oil

(j) Mustard/Rapeseed oil

(k) Nigerseed oil

(l) Palm oil

(m) Phulwara oil

(n) Rice bran oil

(o) Sunflower (Kard/seed) oil

(p) Salseed oil (up to 10%)

(q) Sesame oil

(r) Soyabean oil

(s) Sunflower oil

(t) Watermelon seed oil

(u) Vegetable oils imported for edible purposes:

(2) No vegetable oil shall contain any harmful colouring, flavouring or any other matter deleterious tohealth;

(3) No colour shall be added to hydrogenated vegetable oil unless so authorized by Food Authority, butin no event any colour resembling the colour of ghee shall be added. If any flavour is used, it shall be distinctfrom that of ghee, in accordance with a list of permissible flavours and such quantities as may be prescribedby the Food Authority

(4) No anti-oxidant, synergist, emulsifier or any other such substance be added to any vegetable oilexcept with the prior sanction of the Food Authority

(5) No person shall sell or expose for sale, or distribute, or offer for sale, or dispatch, or deliver to anyperson for the purpose of sale any edible oil –

(a) Which does not conform to the standards of quality as provided in the Food Safety andStandards Act, 2006 (34 of 2006) and rules/regulations made there under; and

(b) Which is not packed in a container, marked and labelled in the manner as specified in FSSAIregulations

Provided that the State Government may, in the public interest, for reasons to be recorded in writing, inspecific circumstances and for a specific period by a notification in the Official Gazette, exempt any edible oilfrom the provisions of this Act.

(6) Restriction on the use of solvent

No solvent other than n-Hexane (Food Grade) shall be used in the extraction of cocoa butter, oilsand fats and edible soya flour.

The quantity solvent mentioned in the column (1) of the Table below, in the food mentioned incolumn (2) of the said Table, shall not exceed the tolerance limits prescribed in column (3) of the saidTable:

Name of Solvent Article of food Tolerance limits mg/kg (ppm)

Hexane (Food Grade) (a) Refined solvent extracted cocoa butter 5.00(b) Refined solvent extracted oils and fats 5.00(c) solvent extracted edible soya flour 10.00

Page 252: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 661

Regulation 7.3.11 Restriction on sale of Kangra tea.

Kangra tea shall be sold or offered for sale only after it is graded and marked in accordance with theprovisions of the Agricultural Produce (Grading and Marking) Act, 1937 (1 of 1937) and the regulations madethereunder.

Regulation 7.3.12: Condition for sale of flavoured tea: Flavoured tea shall be sold or offered for sale only bythose manufacturers who are registered with Tea Board. Registration No. shall be mentioned on the label. It shall besold only in packed conditions with label declaration as provided in the Regulation 4.4.5 (23).

Regulation 7.3.13: Restriction on sale of common salt – No person shall sell or offer or expose for sale orhave in his premises for the purpose of sale, the common salt, for direct human consumption unless the same isiodized:

Provided that common salt may be sold or exposed for sale or stored for sale for iodization, iron fortification,animal use, preservation, manufacturing medicines, and industrial use, under proper label declarations, as specifiedin the Regulation 4.4.5 (21 & 42).

Regulation 7.3.14: Use of flesh of naturally dead animals or fowls prohibited.

No person shall sell or use as an ingredient in the preparation of any article of food intended for sale, the fleshof any animal or fowl which has died on account of natural causes.

Regulation 7.3.15: Special provisions relating to Milk

(1) The Authority shall have power to issue direction relating to any restriction or restraint on free interstatemovement of milk and milk products

(2) The Food Safety Commissioner may, if satisfied that it is necessary to do so to maintain or increase thesupply of liquid milk in any region, direct by order that for the period mentioned in the said order, the distribution ofliquid milk or the production of any milk product by any class or category of producers or manufacturers thereofshall be restricted in such manner as may be specified in the order, provided that no such order shall remain in forcefor more than 90 days at a time. In making this restriction, the Commissioner of Food Safety should have regard tofollowing factors:

(i) The availability of liquid milk in the region;

(ii) Demand for liquid milk by general public in the region;

(iii) Availability of skimmed milk powder and white butter for reconstitution into liquid milk for dairyplants;

(iv) The inter se importance of liquid milk and the concerned milk products proposed to be restrictedand;

(v) Any other factors relevant for maintaining liquid milk supply.

Regulation 7.3.16: Restrictions relating to conditions for sale

(1) No person shall store, expose for sale or permit the sale of any insecticide in the same premises wherearticles of food are stored, manufactured or exposed for sale:

Provided that nothing in this regulation shall apply to the approved household insecticides which havebeen registered as such under the Insecticides Act 1968 (46 of 1968).

Explanation.—For the purpose of this regulation, the word ‘insecticide’ has the same meaning asassigned to it in the Insecticides Act, 1968 (46 of 1968).

(2) No person shall sell or serve food in any “commercial establishment” in plastic articles used in catering andcutlery, unless the plastic material used in catering and cutlery articles, conform to the food grade plastic, specifiedin these regulations.

Explanation :- For the purpose of the Regulation 7.3.16 (2), “commercial establishment” means anyestablishment, called by whatever name, being run\ managed by any person or by any authority of the Government\Semi-Government or by any corporate\ registered body which deals in the business of selling or serving food”.

Page 253: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

662 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(3) Iron fortified common salt shall be sold only in high density polyethylene bag (HDPE) 14 mesh, density 100kg/m3, unlaminated) package which shall bear the lable as specified in the Regulation 4.4.5 (21 & 42).

(4) Table iodized salt or table iron fortified common salt containing anticaking agent shall be sold only in apackage which shall bear the labels as specified in the Regulation 4.4.5 (20)

(5) Dried Glucose Syrup containing sulphur-dioxide exceeding 40 ppm shall be sold only in a package whichshall bear the label as specified in the Regulation 4.4.5 (22)

(6) No person shall manufacture, sell, store or exhibit for sale, an infant milk food, infant formula and milk cerealbased weaning food, processed cereal based weaning food and follow up formula except under Bureau of IndianStandards Certification Mark.

(7) Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder,partly skimmed milk powder and partly skimmed sweetened condensed milk shall not be sold except under IndianStandards Institution Certification Mark.

(8) Every package of cheese (hard), surface treated with Natamycin, shall bear the label as specified in theRegulation 4.4.5 (33).

(9) No person shall sell protein rich atta and protein rich maida except in packed condition mentioning thenames of ingredients on the label.

(10) No person shall sell sal-seed fat for any other purpose except for BAKERY AND CONFECTIONERY andit shall be refined and shall bear the label declaration as specified in the Regulation 4.4.5 (19).

(11) No person shall sell confectionery weighing more than 500 gms. except in packed condition andconfectionery sold in pieces shall be kept in glass or other suitable containers.

Explanation.—for the purposes of Regulation 7.3.16 (11) “Confectionery, shall mean sugar boiled confectionery,lozenges and chewing gum and bubble gum”;

(12) All edible oils, except coconut oil, imported in crude, raw or unrefined form shall be subjected to theprocess of refining before sale for human consumption. Such oil shall bear a label declaration as laid down in theRegulation 4.4.2

(13) The Blended Edible Vegetable Oils shall not be sold in loose form. It shall be sold in sealed packageweighing not more than 15 litres. The container having blended edible vegetable oil shall be tamper proof. It shallalso not be sold under the common or generic name of the oil used in the blend but shall be sold as ‘Blended EdibleVegetable Oil. The sealed package shall be sold or offered for sale only under AGMARK certification mark bearingthe label declarations as provided in the Regulations besides other labelling requirements under the Regulation4.4.2.

(14) Coloured and flavoured table margarine shall only be sold in a sealed package weighing not more than 500gms, with a label declaring addition of colour and flavour as required under these regulations.

(15) The fat spread shall not be sold in loose form. It shall be sold in sealed packages weighing not more than500 gms. The word ‘butter’ shall not be associated while labelling the product. The sealed package shall be sold oroffered for sale only under AGMARK Certification mark bearing the label declaration as provided under Regulation4.4.2 besides other labelling requirements under these regulations.

(16) No person shall sell compounded asafoetida exceeding one kilogram in weight except in a sealed containerwith a label.

(17) No person shall sell powdered spices condiments except ‘under packed conditions.

Explanation :- For the purpose of Regulation 7.3.16 (17) “Spices and Condiments” means the spices andcondiments as specified in Part 5.9.

(18) The katha prepared by bhatti method shall be conspicuously marked as “Bhatti Katha”

(19) No person shall manufacture, sell or exhibit for sale packaged drinking water except under the Bureau ofIndian Standards Certification Mark.

Page 254: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 663

(20) No person shall manufacture, sell or exhibit for sale mineral water except under the Bureau of IndianStandards Certification Mark”;

Explanation:— For the purpose of Regulation 7.3.16 (20), the expression “mineral water” shall have the samemeaning as assigned to it in the Regulation 5.9.7

(21) No person shall sell any food product wherein artificial sweetener is permitted under these regulations,except under packed condition and as per the labelling requirements prescribed under the Regulation 4.4.5 (24, 25,26, 28 & 29)

(22) Conditions for sale of irradiated food.- All irradiated food shall be sold in pre-packed conditions only.The type of packaging material used for irradiated food for sale or for stock for sale or for exhibition for sale or forstorage for sale shall conform to the packaging and labelling requirements specified in the Regulation 4.4.4.

CHAPTER 8CONTAMINANTS, TOXINS AND RESIDUES

Part 8.1 : METAL CONTAMINANTS

Regulations 8.1.1

(1) Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not containmetal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for thetime being in force.

(2) Notwithstanding the provisions of Regulation 8.1.1 (1), no article of food specified in Column 2 of thetable below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table :

Table

Name of the Article of food Parts per Million bymetal weightcontaminants

(1) (2) (3)

(1) Lead (i) Beverages

Concentrated soft drinks (but not including concentrates used in themanufacture of soft drinks) 0.5

Fruit and vegetable juice (including tomato juice, but not includinglime juice and lemon juice) 1.0

Concentrates used in the manufacture of soft drinks, lime juice andlemon juice 2.0

(ia) Baking powder 10

(ib) Edible oils and fats 0.5

(ic) Infant Milk substitute and Infant foods 0.2

(id) Turmeric whole and powder 10.0

(ii) Other foods

Anhydrous dextrose and dextrose monohydrate, refined white sugar(sulphated ash content not exceeding 0.03 per cent) 0.5

Ice-cream, iced lollies and similar frozen Confections 1.0

Canned fish, canned meats, edible gelatin, meat extracts and hydrolysedprotein, dried or dehydrated vegetables (other than onions) 5.0

Page 255: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

664 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

All types of sugar, sugar syrup, invert sugar and direct consumptioncoloured sugars with sulphated ash content exceeding 1.0 per cent 5.0

Raw sugars except those sold for direct consumption or used formanufacturing purpose other than the manufacture of refined sugar. 5.0

Edible molasses, caramel liquid and solid glucose and starch conversionproducts with a sulphated ash content exceeding 1.0 per cent 5.0

Cocoa powder 5.0 on the dry fat freeSubstance

Yeast and yeast products 5.0 on the dry Matter

Tea, dehydrated onions, dried herbs and spices flavourings,alginic acid, alignates, agar, carrageen and similar productsderived from seaweed 10.0 on the dry matter

Liquid pectin, chemicals not otherwise specified, used as ingredientsor in the preparation or processing of food 10.0

Food colouring other than caramel 10.0 on the dry colouringmatter

Solid pectin 50

Hard boiled sugar confectionery 2.0

Iron fortified common salt 2.0

Corned beef, luncheon meat, Cooked Ham, Chopped meat,Canned chicken, Canned mutton and Goat meat and otherrelated meat products. 2.5

Brewed Vinegar and Synthetic Vinegar Nil

(iii) Foods not specified 2.5

(2) Copper (i) Beverages

Soft drinks excluding concentrates and Carbonated water 7.0

Carbonated water 1.5

Toddy 5.0

Concentrates for soft drinks 20.0

(ii) Other Foods

Chicory-dried or roasted, coffee beans, flavorings, 30.0

Colouring 30.0 on dry colouringmatter

Edible gelatin 30.0

Tomato ketchup 50.0 on the dried totalsolids

Yeast and yeast products 60.0 on the dry matter

Cocoa powder 70.0On the fat freesubstance

Tomato puree, paste, powder, juice and cocktails 100.0 on the dried tomatosolid

(1) (2) (3)

Page 256: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 665

Tea 150.0Pectin-solid 300.0Hard boiled sugar confectionery 5.0Iron Fortified Common Salt 2.0Turmeric whole and powder 5.0Juice of orange, grape, apple, tomato, pineapple and lemon 5.0Pulp and pulp products of any fruit 5.0Infant milk substitute and Infant foods 15.0(But not less than 2.8)Brewed Vinegar and Synthetic vinegar NilCaramel 20(iii) Foods not specified 30.0

(3) Arsenic (i) Milk 0.1(ii) Beverages :Soft drink intended for consumption after dilution exceptcarbonated water 0.5Carbonated water 0.25Infant Milk substitute and Infant foods 0.05Turmeric whole and powder 0.1Juice of orange, grape, apple, tomato, pineapple and lemon 0.2Pulp and pulp products of any fruit 0.2Preservatives, anti-oxidants, emulsifying and stabilising agents andsynthetic food colours 3.0 on dry matterIce-cream, iced lollies and similar frozen confections 0.5Dehydrated onions, edible gelatin, liquid pectin 2.0Chicory-dried or roasted 4.0Dried herbs, finings and clearing agents, solid pectin all grades, spices 5.0Food colouring other than synthetic colouring, riboflavin 5.0on dry colouring matterHard boiled sugar confectionery 1.0Iron Fortified Common Salt 1.0Brewed Vinegar and Synthetic Vinegar 0.1(iii) Foods not specified 1.1

(4) Tin (i) Processed and canned products 250.0(i-a) Hard boiled sugar confectionery 5.0(i-aa) Jam, Jellies and Marmalade 250Juice of orange, apple, tomato, pineapple and lemon 250Pulp and pulp products of any fruit 250(i-b) Infant Milk substitute and Infant foods 5.0(i-c) Turmeric whole and powder Nil

(i-d) Corned beef, Luncheon meat, Cooked Ham, Chopped meat,Canned chicken, Canned mutton and Goat meat 250

(1) (2) (3)

Page 257: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

666 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(ii) Foods not specified 250

(5) Zinc (i) Ready-to-drink beverages 5.0

Juice of orange, grape, tomato, pipeapple and lemon 5.0

Pulp and pulp products of any fruit 5.0

(i-a) Infant milk substitute and Infant foods 50.0 (but) not less than25.0)

(ii) Edible gelatin 100.0

(ii-a) Turmeric whole and powder 25.0

(iii) Fruit and Vegetable products 50.0

(iii-a) Hard boiled sugar confectionery 5.0

(iv) Foods not specified 50.0

(6) Cadmium (i) Infant Milk substitute and Infant foods 0.1

(ii) Turmeric whole and powder 0.1

(iii) Other foods 1.5

(7) Mercury Fish 0.5

Other foods 1.0

(8) MethylMercury(calculatedas theelement) All foods 0.25

9.Chromium Refined Sugar 20 ppb

(10) Nickel All hydrogenated, patially hydrogenated, interesterified vegetable oilsand fats such as vanaspati, table margarine, bakery and industrialmargarine, bakery shortening, fat spread and partially hydrogenatedsoyabean oil 1.5

Part: 8.2 Crop contaminants and naturally occuring toxic substances

Regulation 8.2.1

1) Crop contaminant means any substance not intentionally added to food, but which gets added to articlesof food in the process of their production (including operations carried out in crop husbandry, animal husbandryand veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holdingof articles of such food as a result of environmental contamination.

2) No article of food specified in column (2) of the Table below shall contain any crop contaminant specifiedin the corresponding entry in column (1) thereof in excess of quantities specified in the corresponding entry incolumn (3) of the said table :

Sl No Name of the Contaminants Article of Food Limit μg/kg

1. Aflatoxin All articles of food 30

2. Aflatoxin M1 Milk 0.5

3. Patulin Apple juice & Apple juice ingredients in other beverages 50

4. Ochratoxin A Wheat, barley & rye 20

(1) (2) (3)

Page 258: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 667

3) Naturally Occuring Toxic Substances.

The toxic substances specified in column (1) of the Table below, which may occur naturally in any article of food,shall not exceed the limit specified in the corresponding entry in column (2) of the said Table :—

S.No Name of substance Maximum limit

1 Agaric acid 100ppm2 Hydrocyanic acid 5ppm3 Hypericine 1ppm4 Saffrole 10ppm

Part 8.3: Residues

Regulation 8.3.1: Restriction on the use of insecticides.

(1) Subject to the Provisions of Regulation 8.3.1 (2), no insecticides shall be used directly on articles of food:

PROVIDED that nothing in this regulation shall apply to the fumigants which are registered andrecommended for use as such on articles of food by the Registration Committee, constituted under section 5of the Insecticides Act, 1968 (46 of 1968).

(2) The amount of insecticide mentioned in Column 2 on the foods mentioned in column 3, shall not exceed thetolerance limit prescribed in column 4 of the Table given below :

Sl.No.Name of Insecticides Food Tolerance limit mgkg.ppm)

(1) (2) (3) (4)

1. Aldrin, dieldrin (the limits apply to aldrin Foodgrains 0.01and dieldrin singly or in any combination Milled Foodgrains Niland are expressed as dieldrin) Milk and Milk products 0.15 (on a fat basis)

Fruits and Vegetables 0.1

Meat 0.2

Eggs 0.1 (on a shell free basis)

(2) Carbaryl Fish 0.2Food grains 1.5Milled food grains NilOkra and leafy vegetables 10.0Potatoes 0.2Other vegetables 5.0Cottonseed (whole) 1.0Maize cob (kernels) 1.0Rice 2.50Maize 0.50Chillies 5.00

3. Chlordane (residue to be measured as cis Food grains 0.02plus trans chlordane) Milled food grains Nil

Milk and milk products 0.05 (on a fat basis)

Vegetables 0.2

Page 259: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

668 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

Fruits 0.1

Sugar beet 0.3

4. D.D.T. (The limits apply to DDT, DDD and Milk and milk products 1.25 (on a fat basis)DDE singly or in any combination Fruits and vegetables including potato 3.5

Meat, poultry and fish 7.0 (on a whole productbasis

Eggs 0.5 (on a shell free basis)5. D.D.T. (singly) Carbonated Water 0.0016. D.D.D. (singly) Carbonated Water 0.0017. D.D.E. (singly) Carbonated Water 0.0018. Diazinon Foodgrains 0.05

Milled foodgrains NilVegetables 0.5

9. Dichlorvos (content of di- chloroacetaldehyde Foodgrains 1.0(D.C.A.) be reported where possible) Milled foodgrains 0.25

Vegetables 0.15Fruits 0.1

10. Dicofol Fruits and Vegetables 5.0Tea (dry manufactured) 5.0Chillies 1.0

11. Dimethoate (residue to be determined as Fruits and Vegetables 2.0dimethoate and expressed as dimethoate) Chillies 0.5

12. Endosulfan (residues are measured and Fruits and Vegetables 2.0reported as total of endosulfan A and B Cottonseed 0.5and endosulfan-sulphate) Cottonseed oil (crude) 0.2

Bengal gram 0.20Pigeon Pea 0.10Fish 0.20Chillies 1.0Cardamom 1.0

13. Endosulfan A Carbonated Water 0.001

14. Endosulfan B Carbonated Water 0.001

15. Endosulfan-Sulphate Carbonated Water 0.001

16. Fenitrothion Foodgrains 0.02Milled foodgrains 0.005Milk and Milk Products 0.05 (on a fat basis)Fruits 0.5Vegetables 0.3Meat 0.03

Page 260: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

SEC. 4] THE GAZETTE OF INDIA EXTRAORDINARY 669

(1) (2) (3) (4)

17. Heptachlor (combined residues of heptachlor Foodgrains 0.01and its epoxide to be determined and Milled foodgrains 0.002expressed as Heptachlor) Milk and Milk Products 0.15(on a Fat basis)

Vegetables 0.05

18. Hydrogen cyanide Foodgrains 37.5Milled foodgrains 3.0

19. Hydrogen Phosphide Foodgrains NilMilled foodgrains Nil

20. Inorganic bromide (determined and expressed Foodgrains 25.0as total bromide From all sources) Milled Foodgrains 25.0

Fruits 30.0Dried fruits 30.0Spices 400.00

21. Hexachlorocycle hexane and its Isomers Rice grain unpolished 0.10(a) Alfa (á) Isomer: Rice grain polished 0.05

Milk (whole) 0.05Fruits and vegetable 1.00Fish 0.25Carbonated Water 0.001

(b) Beta (â) Isomer : Rice grain Unpolished 0.10Rice grain polished 0.05Milk (whole) 0.02Fruits and vegetable 1.00Fish 0.25Carbonated Water 0.001

(c) Gamma (ã) Isomer (Known as Lindane) Food grains except rice 0.10Milled foodgrains NilRice grain Unpolished 0.10Rice grain polished 0.05Milk 0.01 (onWhole basis)Milk products 0.20 (onfat basis)

Milk products (havinglessthan 2 per cent fat) 0.20 (onWhole basis)Fruits and vegetable 1.00Fish 0.25Eggs 0.10 (On shell free basis)Meat and poultry 2.00 (On Whole basis)Carbonated Water 0.001

(d) Delta (ä) Isomer : Rice grain Unpolished 0.10Rice grain Polished 0.05Milk (whole) 0.02Fruits & vegetables 1.00

Page 261: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

670 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

Fish 0.25Carbonated Water 0.001

22. Malathion (Malathion to bedetermined and Foodgrains 4.0expressed as combined residues ofmalathion Milled foodgrains 1.0and malaoxon) Fruits 4.0

Vegetables 3.0Dried fruits 8.0Carbonated Water 0.001

23. Parathion (Combined residues of parathion Fruits and Vegetables 0.5and paraoxon to be determined andexpressedas parathion)

24. Parathion methyl (combinedresidues of Fruits 0.2parathion methyland its oxygen analogue Vegetables 1.0to be determined and expressed asparathionmethyl)

25. Phosphamidon residues(expressed as the Foodgrains 0.05sum ofphosphamidon and itsdesethyl Milled foodgrains Nilderivative) Fruits and Vegetables 0.2

26. Pyrethrins (sum of pyrethrins I & II and other Foodgrains Nilstructurally related insecticide Ingredients Milled foodgrains Nilof pyrethrum) Fruits and Vegetables 1.0

27. CHLORIENVINPHOS Foodgrains 0.025

Milled Foodgrains 0.006

(Residues to be measured as alpha and Milk and Milk Products 0.02 (fat basis)beta isomers ofChlorienvinphos Meat and Poultry 0.2 (carcass fat)

Vegetables 0.05Groundnuts 0.05 (shellfree basis)Cotton seed 0.05

28. CHLOROBENZILATE Fruits 1.0Dry Fruits, AlmondsAnd Walnuts 0.2 (shellfree basis)

29. CHLORPYRIFOS Foodgrains 0.05Milled foodgrains 0.01Fruits 0.5Potatoes and Onions 0.01Cauli Flower and Cabbage 0.01Other vegetables 0.2Meat and Poultry 0.1 (carcass fat)Milk and Milk Products 0.01(fat basis)Cotton seed 0.05Cottonseed oil (crude) 0.025Carbonated Water 0.001

30. 2,4D Foodgrains 0.01Milled foodgrains 0.003Potatoes 0.2

Page 262: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

SEC. 4] THE GAZETTE OF INDIA EXTRAORDINARY 671

(1) (2) (3) (4)

*Milk and Milk Products 0.05*Meat and Poultry 0.05Eggs 0.05 (shell free basis)Fruits 2.0

31. ETHION (Residues to bedetermined as Tea (dry manufactured) 5.0ethion andIts oxygen analogueand Cucumber and Squash 0.5expressed as ethion) Other Vegetables 1.0

Cotton seed 0.5*Milk and Milk Products 0.5(fat basis)*Meat and Poultry 0.2 (carcass Fat basis)Eggs 0.2 (shell free basis)Foodgrains 0.025Milled foodgrains 0.006Peaches 1.0Other fruits 2.0Dry fruits 0.1 (shell free basis)

32. FORMOTHION(Determined asdinethoate Citrus fruits 0.2and its oxygenAnalogue and expressedas Other fruits 1.0dimethoate except incase of citrus fruits Vegetable 2.0where it is to be determined as formothion) Peppers and Tomatoes 1.0

33. MONOCROTOPHOS Foodgrains 0.025Milled Foodgrains 0.006Citrus fruits 0.2Other fruits 1.0Carrot, Turnip, Potatoesand Sugar beet 0.05Onion and Peas 0.1Other Vegetables 0.2Cottonseed 0.1Cottonseed oil (raw) 0.05*Meat and Poultry 0.02*Milk and Milk Products 0.02Eggs 0.02 (shell free basis)Coffee (Raw beans) 0.1Chillies 0.2Cardamom 0.5

34. PARAQUATDichloride (Determined as Foodgrains 0.1Paraquat cations) Milled foodgrains 0.025

Potato 0.2Other vegetables 0.05Cotton seed 0.2Cottonseed oil (edible refined) 0.05*Milk (whole) 0.01Fruits 0.05

Page 263: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

672 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

35. PHOSALONE Pears 2.0Citrus fruits 1.0Other fruits 5.0Potatoes 0.1Other vegetables 1.0Rapeseed/Mustard Oil (crude) 0.05

36. TRICHLORFON Foodgrains 0.05Milled foodgrains 0.0125Sugar beet 0.05Fruits and Vegetables 0.1Oil seeds 0.1Edible Oil (refined) 0.05*Meat and Poultry 0.1*Milk (whole) 0.05

37. THIOMETON Foodgrains 0.025(Residues determined as Milled foodgrains 0.006thiometon its sulfoxide Fruits 0.5and sulphone expressed Potato, Carrotsand Sugar beets 0.05as thiometon) Other vegetables 2.5

38. Acephate Safflower seed 2.0

Cotton Seed 2.0

39. Methamido-phos Safflower seed 0.1

(A metabolite of Acephate) Cotton seed 0.1

40. Aldicarb (sum ofAldicarb its sulphoxideand sulphone, expressedas Aldicarb) Potato 0.5

Chewing Tobacco 0.1

41. Atrazine Maize Nil

Sugarcane 0.25

42. Carbendazim Foodgrains 0.50

Milled foodgrains 0.12

Vegetables 0.50

Mango 2.00

Banana (whole) 1.00

Other fruits 5.00

Cotton seed 0.10

Groundnut 0.10

Sugar beet 0.10

Dry fruits 0.10

Eggs 0.10 (shell free basis)

Meat & Poultry 0.10 (Carcass fat basis)

Page 264: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

SEC. 4] THE GAZETTE OF INDIA EXTRAORDINARY 673

(1) (2) (3) (4)

Milk & Milk Products 0.10 (fat basis)

43. Benomyl Foodgrains 0.50

Milled foodgrains 0.12

Vegetables 0.50

Mango 2.00

Banana (whole) 1.00

Other fruits 5.00

Cotton seed 0.10

Groundnut 0.10

Sugar beet 0.10

Dry fruits 0.10

Eggs 0.10 (shell free basis)

Meat & Poultry 0.10 (carcass fat basis)

Milk & Milk Products 0.10 (fat basis)

44. Captan Fruit & Vegetables 15.00

45. Carbofuran (sum of Foodgrains 0.10

carbofuran and Milled foodgrains 0.03

3-hydroxy carbofuran Fruit & Vegetables 0.10

expressed as carbofuran) Oil seeds 0.10

Sugarcane 0.10

Meat & Poultry 0.10 (carcass fat basis)

Milk & Milk Products 0.05 (fat basis)

46. Copper Oxychloride Fruit 20.00

(determined as copper) Potato 1.00

Other vegetables 20.00

47. Cypermethrin (sum of isomers) Wheat grains 0.05(fat soluble residue) Milled wheat grains 0.01

Brinjal 0.20Cabbage 2.00Bhindi 0.20Oil seeds except groundnut 0.20Meat and Poultry 0.20 (carcass fat basisMilk and Milk Products 0.01 (fat basis)

48. Decamethrin / Deltamethrin Cotton Seed 0.10Food grains 0.50Milled Foodgrains 0.20Rice 0.05

49. Edifenphos Rice 0.02

Page 265: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

674 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

Rice bran 1.00Eggs 0.01(shell free basis)Meat and poultry 0.02 (carcass fat basis)Milk and Milk products 0.01 fat basis)

50. Fenthion (sum of fenthion, its oxygen Food grains 0.10analogue and their sulphoxides and Milled food grains 0.03sulphones expressed as fenthion) Potatoes 0.05

Beans 0.10Peas 0.50Tomatoes 0.50Other vegetables 1.00Musk melon 2.00Meat and Poultry 2.00 (carcasss fat basis)Milk and Milk products 0.05 (fat basis)

51. Fenvalerate (fat soluble residue) Cauliflower 2.00Brinjal 2.00Okra 2.00Cotton Seed 0.20Cotton seed oil 0.10Meat and Poultry 1.00 (carcass fat basis)Milk and Milk Product 0.01 (fat basis)

52. Dithiocarbamates (the residue tolerance Food Grains 0.20limit are determined and expressed asmg/CS2/kg and refer separately to theresidues arising from any or each groupof dithiocarbamates

(a) Dimethyl dithiocarbamates residue Milled food grains 0.05resulting from the use of ferbam or ziram, and Potatoes 0.10

Tomatoes 3.00

(b) Ethylene bis- dithiocarbamates resulting Cherries 1.00from the use of mancozeb, maneb or zineb Other fruits 3.00(including zineb derived from nabam Chillies 1.0plus zinc sulphate)

(c) Mancozeb

53. Phenthoate Foodgrains 0.05Milled foodgrains 0.01Oilseeds 0.03Edible oils 0.01Eggs 0.05 (shell free basis)Meat & Poultry 0.05 (carcass fat basis)Milk & Milk products 0.01 (fat basis)

54. Phorate (sum ofPhorate, its oxygenanalogue Foodgrains 0.05and theirsulphoxides and sulphones, Milled foodgrains 0.01expressed as phorate) Tomatoes 0.10

Page 266: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

SEC. 4] THE GAZETTE OF INDIA EXTRAORDINARY 675

(1) (2) (3) (4)

Other vegetables 0.05Fruits 0.05Oil seeds 0.05Edible oils 0.03Sugarcane 0.05Eggs 0.05 (shell free basis)Meat & Poultry 0.05 (carcass fat basis)Milk & Milk Products 0.05 (fat basis)

55. Simazine Maize NilSugarcane 0.25

56. Pirimiphos-methyl Rice 0.50Food grains except rice 5.00Milled food grains except rice 1.00Eggs 0.05 (shell free basis)Meat & Poultry 0.05 (carcass fat basis)Milk & Milk Products 0.05 (fat basis)

57. Alachlor Cotton Seed 0.05Groundnut 0.05Maize 0.10Soyabeans 0.10

58. Alfa Nephthyl AceticAcid (A.N.A.) Pine-Apple 0.50

59. Bitertanol Wheat 0.05Groundnut 0.10

60. Captafol Tomato 5.00

61. Cartaphydrochloride Rice 0.50

62. Chlormequatchloride Grape 1.00Cotton Seed 1.00

63. Chlorothalonil Groundnut 0.10Potato 0.10

64. Diflubenzuron Cotton Seed 0.2065. Dodine Apple 5.0066. Diuron Cotton Seed 1.00

Banana 0.10Maize 0.50Citrus 1.00(Sweet Orange)Grapes 1.00

67. Ethephon Pine Apple 2.00Coffee 0.10Tomato 2.00Mango 2.00

68. Fluchloralin Cotton Seed 0.05

Page 267: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

676 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

Soya Beans 0.05

69. Malic Hydrazide Onion 15.00Potato 50.00

70. Metalyxyl Bajra 0.05Maize 0.05Sorghum 0.05

71. Methomyl Cotton Seed 0.10

72. Methyl Chloro-phenoxy-acetic Acid Rice 0.05(M.C.P.A.) Wheat 0.05

73. Oxadiazon Rice 0.03

74. Oxydemeton methyl Food-grains 0.02

75. Permethrin Cucumber 0.50Cotton Seed 0.50Soya Beans 0.05Sunflower Seed 1.00

76. Quinolphos Rice 0.01Pigeon pea 0.01Cardamom 0.01Tea 0.01Fish 0.01Chillies 0.2

77. Thiophenatemethyl Apple 5.00Papaya 7.00

78. Triazophos Chillies 0.2Rice 0.05Cotton seed oil 0.1Soyabean oil 0.05

79. Profenofos Cotton seed oil 0.05

80. Fenpropathrin Cotton seed oil 0.05

81. Fenarimol Apple 5.0

82. Hexaconazole Apple 0.1

83. Iprodione Rape seed 0.5Mustard seed 0.5Rice 10.0Tomato 5.0Grapes 10.0

84. Tridemorph Wheat 0.1Grapes 0.5Mango 0.05

Page 268: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

SEC. 4] THE GAZETTE OF INDIA EXTRAORDINARY 677

(1) (2) (3) (4)

85. Penconazole Grapes 0.2

86. Propiconazole Wheat 0.05

87. Myclobutanil Groundnut seed 0.1Grapes 1.0

88. Sulfosulfuron Wheat 0.02

89. Trifluralin Wheat 0.05

90. Ethoxysulfuron Rice 0.01

91. Metolachlor Soyabean Oil 0.05

92. Glyphosphate Tea 1.0

93. Linuron Pea 0.05

94. Oxyfluorfen Rice 0.05Groundnut Oil 0.05

95. Carbosulfan Rice 0.2

96. Tricyclazole Rice 0.02

97. Imidacloprid Cotton seed Oil 0.05Rice 0.05

98. Butachlor Rice 0.05

99. Chlorimuron-ethyl Wheat 0.05

100. Diclofop-methyl Wheat 0.1

101. Metribuzin Soyabean Oil 0.1

102. Lambdacyhalothrin Cotton seed Oil 0.05

103. Fenazaquin Tea 3.0

104. Pendimethalin Wheat 0.05Rice 0.05Soyabean Oil 0.05Cotton seed Oil 0.05

105. Pretilachlor Rice 0.05

106. Fluvalinate Cotton seed Oil 0.05

107. Metasulfuron-methyl Wheat 0.1

108. Methabenzthiazuron Wheat 0.5

109. Imazethapyr Soyabean oil 0.1Groundnut oil 0.1

110. Cyhalofop-butyl Rice 0.5

111. Triallate Wheat 0.05

112. Spinosad Cotton seed oil 0.02Cabbage 0.02Cauliflower 0.02

Page 269: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

678 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—

(1) (2) (3) (4)

113. Thiamethoxam Rice 0.02

114. Fenobucarb Rice 0.01

115. Thiodicarb Cotton seed oil 0.02

116. Anilophos Rice 0.1

117. Fenoxy-prop-p-ethyl Wheat 0.02Soyabean seed 0.02

118. Glufosinate-ammonium Tea 0.01

119. Clodinafop-propanyl Wheat 0.1

120. Dithianon Apple 0.1

121. Kitazin Rice 0.2

122. Isoprothiolane Rice 0.1

123. Acetamiprid Cotton seed oil 0.1

124. Cymoxanil Grapes 0.1

125. Triadimefon Wheat 0.5Pea 0.1Grapes 2.0

126. Fosetyl-A1 Grapes 10Cardamom 0.2

127. Isoproturon Wheat 0.1

128. Propargite Tea 10.0

129. Difenoconazole Apple 0.01

130. b-Cyfluthrin Cotton seed 0.02

131. Ethofenprox Rice 0.01

132. Bifenthrin Cotton seed 0.05

133. Benfuracarb Red Gram 0.05Rice 0.05

134. Quizalofop-ethyl Soyabean seed 0.05

135. Flufenacet Rice 0.05

136. Buprofezin Rice 0.05

137. Dimethomorph Grapes 0.05Potatoes 0.05

138. Chlorfenopyr Cabbage 0.05

139. Indoxacarb Cotton seed 0.1Cottonseed oil 0.1Cabbage 0.1

140. Metiram Tomato 5.0Ground nut seed 0.1

Page 270: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 679

Ground nut seed oil 0.1

141. Lufenuron Cabbage 0.3

142. Carpropamid Rice 1.0

143. Novaluron Cottonseed 0.01Cottonseed oil 0.01Tomato 0.01Cabbage 0.01

144. Oxadiargyl Rice 0.1

145. Pyrazosulfuron ethyl Rice 0.01

146. Clomazone Rice 0.01Soyabean seed 0.01Soyabean seed oil 0.01

147. Tebuconazole Wheat 0.05

148. Propineb Apple 1.0

Pomegranate 0.5

Potato 0.5Green Chillies 2.0Grapes 0.5

149. Thiochlorprid Cotton seed 0.05Cotton seed oil 0.05Rice 0.01

Explanation :- For the purpose of this regulation :(a) the expression “insecticide” shall have the meaning assigned to it in the Insecticide Act, 1968 (46 of

1968);(b) unless otherwise stated :

(i) maximum levels are expressed in mg./kg. on a whole product basis.(ii) all foods refer to raw agricultural products moving in commerce.

Regulation 8.3.2: Antibiotic and Other Pharma-cologically Active Substances

(1) The amount of antibiotic mentioned in column (2), on the sea foods including shrimps, prawns or anyother variety of fish and fishery products, shall not exceed the tolerance limit prescribed in column (3) of the tablegiven below:—

Table

S.No. Name of Antibiotics Tolerance limit mg/kg (ppm)

1. Tetracycline 0.12. Oxytetracycline 0.13. Trimethoprim 0.054. Oxolinic acid 0.3

(2) The use of any of the following antibiotics and other Pharmacologically Active Substances shall beprohibited in any unit processing sea foods including shrimps, prawns or any other variety of fish and fisheryproducts —

(1) (2) (3) (4)

Page 271: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

680 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(i) All Nitrofurans including

(ii) Furaltadone

(iii) Furazolidone

(iv) Furylfuramide

(v) Nifuratel

(vi) Nifuroxime

(vii) Nifurprazine

(viii) Nitrofurnatoin

(ix) Nitrofurazone

(x) Chloramphenicol

(xi) Neomycin

(xii) Nalidixic acid

(xiii) Sulphamethoxazole

(xiv) Aristolochia spp and preparations thereof

(xv) Chloroform

(xvi) Chloropromazine

(xvii) Cholchicine

(xviii) Dapsone

(xix) Dimetridazole

(xx) Metronidazole

(xxi) Ronidazole

(xxii) Ipronidazole

(xxiii) Other nitromidazoles

(xxiv) Clenbuterol

(xxv) Diethylstibestrol (DES)

(xxvi) Sulfanoamide drugs (except approved Sulfadimethoxine, Sulfabromomethazine andSulfaethoxypyridazine)

(xxvii) Fluoroquinolones

(xxviii) Glycopeptides.

CHAPTER 9

LABORATORY AND SAMPLE ANALYSIS

Part 9.1: Referral Laboratory

Regulation 9.1.1: Functions- In addition to the functions entrusted to it under the Act, the Referral Laboratoryshall carry out the following functions, namely:

(1) analysis of samples of food sent by any officer or authority authorized by the Food Authority for thepurpose and submission of the certificate of analysis to the authorities concerned;

(2) investigation for the purpose of fixation of standard of any article of food;

Page 272: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 681

(3) investigation in collaboration with the laboratories of Food analysts in the various States and suchother laboratories and institutions which the Food Authority may approve on its behalf, for the purpose ofstandardizing methods of analysis.

(4) ensuring that the laboratory follows the scientific protocols laid down for handling/testing thearticles of food.

(5) maintaining high standards of accuracy, reliability and credibility in the operation of the laboratoryand achieving and maintaining the required levels of accreditation and reliability.

(6) laying down mechanism for ensuring that personnel of the laboratory adhere to high professionalstandards and discipline.

(7) Such other conditions, as the Authority may lay down for Referral Laboratories.

(8) Capacity building by way of organizing professional training, workshops and seminars for the Foodanalyst, lab personnel of the lab in the states specified by the Food authority.

Regulation 9.1.2: State/ Union Territory/ Local Area of Referral Laboratory

(1) The laboratory specified in Col.(1) of Table I below, shall carry out the functions entrusted to it by the Actor these regulations in respect of the local areas specified in the corresponding entry in Col.(2) thereof.

Table-I

Name of the Referral Laboratory Local Areas/ State / UT

1. Referral Food Laboratory, Kolkata -700016 Arunachal Pradesh, Assam, Chhatisgarh, Manipur,Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura,Uttarakhand and Union Territories of Andaman and NicobarIsland and Lakshadweep

2. Referral Food Laboratory, Mysore – 570013 Gujarat, Haryana, Himachal Pradesh, Maharashtra, Punjab,Uttar Pradesh and Union Terriory of Chandigarh

3. Referral Food Laboratory, Pune Andhra Pradesh, Delhi, Jammu and Kashmir, Karnataka,Kerala, Rajasthan and Tamil Nadu

4. Referral Food Laboratory, Ghaziabad Bihar, Goa, Jharkhand, Madhya Pradesh, West Bengal, UnionTerritories of Dadar and Nagar Haveli, Daman & Diu andPondicherry.

(2) The certificate of analysis to be provided by the referral food laboratory shall be as per Form C, AppendixC.

Regulation 9.1.3: Notified Laboratories for Import

(1) The sample of any imported article will be sent by the authorized officer for analysis. The Food Analyst ofany of the following notified laboratories or any other laboratories notified by the food Authority from time to time.having jurisdiction over the area in which the sample was taken.

Sl. No. Name of the laboratory Local area

1. Central Food Laboratory, Calcutta All Seaports/Airports/Container: Depots in the UnionTerritories/ States of - (i) The Andaman and Nicobar Islands,(ii) Andhra Pradesh, (iii) Arunachal Pradesh (iv) Assam (v)Bihar (vi) Manipur (vii) Meghalaya (viii) Mizoram (ix) Nagaland(x) Orissa (xi) Sikkim (xii) Tripura (xiii) West Bengal and (xiv)Jharkhand International borders in the States of - (i)_Arunachal Pradesh, (ii) Assam, (iii) Bihar (iv) Manipur (v)Meghalaya (vi) Mizoram (vii) Nagaland (viii) Sikkim (ix) Tripura(x) West Bengal

Page 273: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

682 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

2. Central Food Laboratory, Ghaziabad All Airports / Inland Container Depots in the Union Territories/States of - (i) Chandigarh, (ii) Delhi, (iii) Haryana, (iv) HimachalPradesh, (v) Jammu and Kashmir (vi) Madhya Pradesh (vii)Punjab (viii) Rajasthan (ix) Uttar Pradesh (x) Chhatisgarh (xi)UttarakhandAll International borders in the states of (i)Himachal Pradesh (ii) Rajasthan (iii) Jammu and Kashmir (iv)Punjab, (v) Uttar Pradesh (vi) and Uttarakhand

3. Central Food Laboratory, Mysore All Airports/ Inland Container Depots in the Union territoriesState of (i) Karnataka, (ii) Kerala, (iii) Lakshadweep, (iv)Puducherry and (v) Tamil Nadu

4. Central Food Laboratory, Pune All Airports/ Inland Container Depots in the Union Territories/States of (i) Dadra and Nagar Haveli, (ii) Daman and Diu, (iii)Goa, (iv) Gujarat and, (v) MaharashtraAll International bordersin the state of (i) Gujarat

Part 9.2 Procedure of Sampling

Regulation 9.2.1: Quantity of sample to be sent to the Food analyst means the quantity of sample of food tobe sent to the Food Analyst /Director for analysis shall be as specified in the regulation by the Authority:

Table 9.2.1

Sr. No Article of Food Aproximate Quantityto be supplied

(1) (2) (3)

1. Milk 500 ml.

2. Sterilized Milk / UHT Milk 500 ml.

3. Malai / Dahi 200 gms.

4. Yoghurt / Sweetened Dahi 500 gms..

5. Chhana / Paneer / Khoya / Shrikhand 250 gms.

6. Cheese/Cheese spread 200 gms.

7. Evaporated Milk/Condensed Milk 200 gms.

8. Ice-Cream/Softy/Kulfi/Icecandy/Icelolly 300 gms.

9. Milk Powder/Skimmed Milk Powder 250 gms.

10. Infant Food/Weaning Food 500 gms.

11. Malt Food/Malted Milk Food 300 gms.

12. Butter/Butter Oil/Ghee/Margarine/ Cream/Bakery Shortening 200 gms.

13. Vanaspati, Edible Oils/Fats 400 gms.

14. Carbonated Water 3 ltr.

15. Baking Powder 100 gms.

16. Arrow root/Sago 250 gms.

17. Corn flakes/Macaroni Products/Corn Flour/Custard Powder 200 gms.

18. Spices, Condiments and Mixed Masala (Whole) 500 gms.

19. Spices, Condiments and Mixed Masala (Powder) 500 gms.

Page 274: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 683

20. Nutrneg/Mace 250 gms.

21. Asafoetida 100 gms.

22. Compounded Asafoetida 150 gms.

23. Saffron 20 gms.

24. Gur/jaggery, Icing Sugar, Honey, Synthetic Syrup, Bura 250 gms.

25. Cane Sugar/Refined Sugar/Cube sugar, Dextrose, Misri/Dried Glucose Syrup. 200 gms.

26. Artificial Sweetener 100 gm.

27. Fruit Juice/Fruit Drink/Fruit Squash 1 ltr.

28. Tomato Sauce/Ketch up/Tamato Paste, jam/jelly/Marmalade/Tomato Puree/Vegetable Sauce 300 gms.

29. None Fruit Jellies 200 gms.

30. Pickles and Chutneys 250 gms.

31. Oilseeds / Nuts /Dry Fruits 250 gms.

32. Tea/Roasted Coffee/Roasted Chicory 500 gms.

33. Instant Tea/Instant Coffee/Instant Coffee-Chicory Mixture 100 gms.

34. Sugar Confectionery/Chewing gum/Bubble Gum 200 gms.

35. Chocolates 200 gms.

36. Edible Salt 200 gms.

37. Lodised Salt/Iron Fortified Salt 200 gms.

38. Food Grains and Pulses (Whole and Split) 1 kg.

39. Atta/Maida/Suji/Besan/Other Milled Product/Paushtik and Fortified Atta/Maida 500 gms.

40. Biscuits and Rusks 200 gms.

41. Bread/Cakes/Pasties 250 gms.

42. Gelatin 150 gms.

43. Catechu 150 gms.

44. Vinegar/Synthetic Vinegar 300 gms.

45. Food colour 25 gms.

46. Food colour preparation (Solid/Liquid) 25 gm. Solid/100 mlliquid

47. Natural Mineral Water/Packaged Drinking Water 4000ml in threeminimum originalsealed packs.

48. Silver Leafs 2 gm.

49 Prepared Food 500 gms.

50. Proprietary Food, (Non Standardised Foods) 500 gms.

51. Canned Foods 6 sealed cans

52. Food not specified 500 gms

(2) After test or analysis, the certificate thereof shall be supplied forthwith to the sender in Form D, Appendix C.

(1) (2) (3)

Page 275: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

684 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

(3) The fees payable in respect of such a certificate shall be (Rs. 1000) per sample of food analysed asprescribed by the Food Authority.

(4) Certificates issued under these regulations by the laboratory shall be signed by the Director.

(5) Preservative in respect of milk, cream, dahi, Khoa or khoa based and Paneer based sweets, such as,Kalakand and Burfi, Chutney and prepared foods and gur prepared coffee and prepared tea – The preservative usedin the case of samples of any milk (including toned, separated and skimmed milk), standardised milk chhanna,skimmed milk channa, cream, ice-candy, dahi, khoa or khoa based and Paneer based sweets, such as Kalakand andBurfi, Chutney and prepared foods and gur coffee and tea in liquid or semi-liquid form shall be the liquid commonlyknown as “formalin”, that is to say, liquid containing about 40 per cent of formaldehyde in aqueous solution in theproportion of 0.1 ml. (two drops) for 25 ml. or 25 grams.

Provided that in case of samples of ice-cream and mixed ice-cream, the preservative used shall be liquidcommonly known as formalin, that is to say, a liquid containing about 40 per cent, of formaldehyde in aqueoussolution in the proportion of 0.6 ml. for 100 ml. or 100 gms.

CHAPTER 10OTHERS

Part 10.1: Guarantee

Regulation 10.1.1- Every manufacturer, distributor or dealer selling an article of food to a vendor shall giveeither separately or in the bill, cash memo, or label a warranty in Form A. (Refer Form A for form of Guarantee).

Page 276: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 685

Appendix A List of Food Additives

1. International Numbering System (INS) for Food Additives :–

The following list sorted by INS is only for identifying the INS No. of these food additives or their synonyms as per Codex. The list of food additive as per Codex and the food additives allowed under the Food Safety and Standards Regulations, 2010 are listed in these regulations including Appendices

The list given below as published by Codex as on date (23 -11-2005). For any revision JECFA/Code website may be referred (www.codexalimentarius.net, www.codexalimentarius.net/web/jecfa.jsp)

A. List sorted by INS number

Sl.No. INS Number Food Additive Name Technical functions

1. 100 Curcumins Colour

2. 100(i) Curcumin Colour

3. 100(ii) Turmeric Colour

4. 101 Riboflavins Colour

5. 101(i) Riboflavin Colour

6. 101(ii) Riboflavin 5’-phosphate, sodium Colour

7. 102 Tartrazine Colour

8. 103 Alkanet Colour

9. 104 Quinoline yellow Colour

10. 107 Yellow 2G Colour

11. 110 Sunset yellow FCF Colour

12. 120 Carmines Colour

13. 121 Citrus red 2 Colour

14. 122 Azorubine / Carmoisine Colour

15. 123 Amaranth Colour

16. 124 Ponceau 4R Colour

17. 125 Ponceau SX Colour

18. 127 Erythrosine Colour

19. 128 Red 2G Colour

20. 129 Allurared AC/Fast Red E Colour

21. 130 Manascorubin Colour

22. 131 Patent blue V Colour

23. 132 Indigotine Colour

24. 133 Brilliant blue FCF Colour

25. 140 Chlorophyll Colour

26. 141 Copper chlorophylls Colour

27. 141(i) Chlorophyll copper complex, Colour

28. 141(ii) Chlorophyll copper complex, sodium and potassium Salts

Colour

29. 142 Green S Colour

30. 143 Fast green FCF Colour

31. 150a Caramel I-plain Colour

32. 150b Caramel II – caustic sulphite process Colour

Page 277: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

686 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

33. 150c Caramel III – ammonia process Colour

34. 150d Caramel IV-ammonia sulphite Process Colour

35. 151 Brilliant black PN Colour

36. 152 Carbon black (hydrocarbon) Colour

37. 153 Vegetable carbon Colour

38. 154 Brown FK Colour

39. 155 Brown HT Colour

40. 160a Carotenes Colour

41. 160a(i) Beta-carotene (synthetic) Colour

42. 160a(ii) Natural extracts Colour

43. 160b Annatto extracts Colour

44. 160c Paprika Oleoresins Colour

45. 160d Lycopene Colour

46. 160e Beta-apo-carotental Colour

47. 160f Beta-apo-8’-carotenic acid, methyl or ethyl ester

Colour

48. 161a Flavoxanthin Colour

49. 161b Lutein Colour

50. 161c Krytoxanthin Colour

51. 161d Rubixanthin Colour

52. 161e Violoxanthin Colour

53. 161f Rhodoxanthin Colour

54. 161g Canthaxanthin Colour

55. 162 Beet red Colour

56. 163 Anthocyanins Colour

57. 163(i) Anthocyanins Colour

58. 163(ii) Grape skin extract Colour

59. 163(iii) Blackcurrant extract Colour

60. 164 Gardenia yellow Colour

61. 166 Sandalwood Colour

62. 170 Calcium carbonates Surface colourant, anticaking agent, stabilizer

63. 170(i) Calcium carbonate anticaking agent

64. 170(ii) Calcium hydrogen carbonate anticaking agent

65. 171 Titanium dioxide Colour

66. 172 Iron oxides Colour

67. 172(i) Iron oxide, black Colour

68. 172(ii) Iron oxide, red Colour

69. 172(iii) Iron oxide, yellow Colour

70. 173 Aluminium Colour

71. 174 Silver Colour

72. 175 Gold Colour

73. 180 Lithol rubine BK Colour

Page 278: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 687

Sl.No. INS Number Food Additive Name Technical functions

74. 181 Tannins, food grade Colour, emulsifier, stabilizer, thickener

75. 182 Orchil Colour

76. 200 Sorbic acid Preservative

77. 201 Sodium sorbate Preservative

78. 202 Potassium sorbate Preservative

79. 203 Calcium sorbate Preservative

80. 209 Heptyl p-hydroxybenzoate Preservative

81. 210 Benzoic acid Preservative

82. 211 Sodium benzoate Preservative

83. 212 Potassium benzoate Preservative

84. 213 Calcium benzoate Preservative

85. 214 Ethyl p-hydroxybenzoate Preservative

86. 215 Sodium ethyl p-hydroxybenzoate Preservative

87. 216 Propyl p-hydroxybenzoate Preservative

88. 217 Sodium propyl p-hydroxybenzoate Preservative

89. 218 Methyl p-hydroxybenzoate Preservative

90. 219 Sodium methyl p-hydroxybenzoate Preservative

91. 220 Sulphur dioxide Preservative, antioxidant

92. 221 Sodium sulphite Preservative, antioxidant

93. 222 Sodium hydrogen sulphite Preservative, antioxidant

94. 223 Sodium metabisulphite Preservative, bleaching agent, antioxidant

95. 224 Potassium metabisulphite Preservative, antioxidant

96. 225 Potassium sulphite Preservative, antioxidant

97. 226 Calcium sulphite Preservative, antioxidant

98. 227 Calcium hydrogen sulphite Preservative, antioxidant

99. 228 Potassium bisulphate Preservative, antioxidant

100. 230 Diphenyl Preservative

101. 231 Ortho-phenylphenol Preservative

102. 232 Sodium o-phenylphenol Preservative

103. 233 Thiabendazole Preservative

104. 234 Nisin Preservative

105. 235 Pimaricin (natamycin) Preservative

106. 236 Formic acid Preservative

107. 237 Sodium formate Preservative

108. 238 Calcium formate Preservative

109. 239 Hexamethylene tetramine Preservative

110. 240 Formaldehyde Preservative

111. 241 Gum guaicum Preservative

112. 242 Dimethyl dicarbonate Preservative

113. 249 Potassium nitrite Preservative, colour fixative

114. 250 Sodium nitrite Preservative, colour fixative

Page 279: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

688 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

115. 251 Sodium nitrate Preservative, colour fixative

116. 252 Potassium nitrate Preservative, colour fixative

117. 260 Acetic acid, glacial Preservative, acidity regulator

118. 261 Potassium acetates Preservative, acidity regulator

119. 261(i) Potassium acetate Preservative, acidity regulator

120. 261(ii) Potassium diacetate Preservative, acidity regulator

121. 262 Sodium acetates Preservative, acidity regulator, Sequestrant

122. 262(i) Sodium acetate Preservative, acidity regulator, Sequestrant

123. 262(ii) Sodium diacetate Preservative, acidity regulator, Sequestrant

124. 263 Calcium acetate Preservative, stabilizer, acidity Regulator

125. 264 Ammonium acetate Acidity regulator

126. 265 Dehydroacetic acid Preservative

127. 266 Sodium dehydroacetate Preservative

128. 270 Lactic acid (L-, D—and Dl-) Acidity regulator

129. 280 Propionic acid Preservative

130. 281 Sodium propionate Preservative

131. 282 Calcium propionate Preservative

132. 283 Potassium propionate Preservative

133. 290 Carbon dioxide Carbonating agent, Packing agent

134. 296 Malic acid (DL-L-) Acidity regulator, flavouring agent.

135. 297 Fumaric acid acidity regulator

136. 300 Ascorbic acid (L) Antioxidant

137. 301 Sodium ascorbate Antioxidant

138. 302 Calcium ascorbate Antioxidant

139. 303 Potassium ascorbate Antioxidant

140. 304 Ascorbyl palmitate Antioxidant

141. 305 Ascorbyl stearate Antioxidant

142. 306 Mixed tocopherols Antioxidant

143. 307 Alpha-tocopherol Antioxidant

144. 308 Synthetic gamma-tocopherol Antioxidant

145. 309 Synthetic delta-tocopherol Antioxidant

146. 310 Propyl gallate Antioxidant

147. 311 Octyl gallate Antioxidant

148. 312 Dodecyl gallate Antioxidant

149. 313 Ethyl gallate Antioxidant

150. 314 Guaiac resin Antioxidant

151. 315 Isoascorbic acid Antioxidant

152. 316 Sodium isoascorbate Antioxidant

153. 317 Potassium isoascorbate Antioxidant

154. 318 Calcium isoascrobate Antioxidant

155. 319 Tertiary butylhydroquinone Antioxidant

Page 280: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 689

Sl.No. INS Number Food Additive Name Technical functions

156. 320 Butylated hydroxyanisole Antioxidant

157. 321 Butylated hydroxytoluene Antioxidant

158. 322 Lecithins Antioxidant, emulsifier

159. 323 Anoxomer Antioxidant

160. 324 Ethoxyquin Antioxidant

161. 325 Sodium lactate antioxidant, synergist, humectant, bulking agent

162. 326 Potassium lactate antioxidant, synergist, acidity Regulator

163. 327 Calcium lactate acidity regulator, flour treatment agent

164. 328 Ammonium lactate acidity regulator, flour treatment agent

165. 329 Magnesium lactate (D-,L-) acidity regulator, flour treatment agent

166. 330 Citric acid acidity regulator, synergist for Sequestrant

167. 331 Sodium citrates acidity regulator, sequestrant emulsifier stabilizer

168. 331(i) Sodium dihydrogen citrate acidity regulator, sequestrant emulsifer, stabilizer

169. 331(ii) Disodium monohydrogen citrate acidity regulator, stabilizer, sequestrant, emulsifier

170. 331(iii) Trisodium citrate acidity regulator, sequestrant, emulsifier, Stabilizer

171. 332 Potassium citrates acidity regulator, sequestrant, Stabilizer

172. 332(i) Potassium dihydrogen citrate acidity regulator, sequestrant, Stabilizer

173. 332(ii) Tripotassium citrate acidity regulator, sequestrant, Stabilizer

174. 333 calcium citrates acidity regulator, firming agent, Sequestrant

175. 334 Tartaric acid [L(+)-] acidity regulator, sequestrant, antioxidant synergist

176. 335 Sodium tartrates Stabilizer, sequestrant,

177. 335(i) Monosodium tartrate Stabilizer, sequestrant

178. 335(ii) Disodium tartrate Stabilizer, sequestrant

179. 336 Potassium tartrate Stabilizer, sequestrant

180. 336(i) Monopotassium tartrate Stabilizer, sequestrant

181. 336(ii) Dipotassium tartrate Stabilizer, sequestrant

182. 337 Potassium sodium tartrate Stabilizer, sequestrant

183. 338 Orthophosphoric acid acidity regulator, antioxidant Synergist

184. 339 Sodium phosphates acidity regulator, texturizer, sequestrant, stabilizer Emulsifier, water retention agent

185. 339(i) Monosodium orthophosphate Acidity regulator, texturizer, Sequestrant, stabilizer, Emulsifier, water retention agent

186. 339(ii) Disodium orthophosphate acidity regulator, texturizer, sequestrant, stabilizer Emulsifier, water retention agent

187. 339(iii) Trisodium orthophosphate sequestrant, stabilizer, Emulsifier, water retention agent, acidity regulator, Texturizer

188. 340 Potassium Phosphates acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

189. 340(i) Monopotassium orthophosphate acidity regulator, texturizer, sequestrant, stabilizer Emulsifier, water retention Agent

190. 340(ii) Dipotassium orthophosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

191. 340(iii) Tripotassium orthophosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

Page 281: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

690 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

192. 341 Calcium phosphates acidity regulator, texturizer, water retention agent, flour treatment agent, raising agent, firming agent, anticaking agent

193. 341(i) Monocalcium orthophosphate acidity regulator, texturizer, water retention agent, flour treatment agent, firming agent, anticaking agent

194. 341(ii) Dicalcium orthophosphate acidity regulator, texturizer, flour treatment agent, raising agent, firming agent, anticaking Agent

195. 341(iii) Tricalcium orthophosphate acidity regulator, texturizer, water retention agent, flour treatment agent, firming agent, anticaking agent

196. 342 Ammonium phosphates acidity regulator, flour treatment agent

197. 342(i) Monoamonium orthophosphate acidity regulator, flour treatment agent

198. 342(ii) Diammonium orthophosphate acidity regulator, flour treatment agent

199. 343 Magnesium phosphates acidity regulator, anticaking Agent

200. 343(i) Monomagnesium orthophosphate acidity regulator, anticaking Agent

201. 343(ii) Dimagnesium orthophosphate acidity regluator, anticaking Agent

202. 343(iii) Trimagnesium orthophosphate acidity regulator, anticaking Agent

203. 344 Lecithin citrate Preservative

204. 345 Magnesium citrate acidity regulator

205. 349 Ammonium malate acidity regulator

206. 350 Sodium malates acidity regulator, humectant

207. 350(i) Sodium hydrogen malate acidity regulator, humectant

208. 350(ii) Sodium malate acidity regulator, humectant

209. 351 Potassium malates. acidity regulator

210. 351(i) Potassium hydrogen malate acidity regulator

211. 351(ii) Potassium malate acidity regulator

212. 352 Calcium malates acidity regulator

213. 352(i) Calcium hydrogen malate acidity regulator

214. 352(ii) Calcium malate acidity regulator

215. 353 Metatartaric acid acidity regulator

216. 354 Calcium tartrate acidity regulator

217. 355 Adipic acid acidity regulator

218. 356 Sodium adipates acidity regulator

219. 357 Potassium adipates acidity regulator

220. 359 Ammonium adipates acidity regulator

221. 363 Succinic acid acidity regulator

222. 364(i) Monosodium succinate acidity regulator, flavour Enhancer

223. 364(ii) Disodium succinate acidity regulator, flavour Enhancer

224. 365 Sodium fumarates acidity regulator

225. 366 Potassium fumarates acidity regulator

226. 367 Calcium fumarates acidity regulator

227. 368 Ammonium fumarates acidity regulator

Page 282: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 691

Sl.No. INS Number Food Additive Name Technical functions

228. 370 1, 4-Heptonolactone acidity regulator, sequestrant

229. 375 Nicotinic acid Colour retention agent

230. 380 Ammonium citrates acidity regulator

231. 381 Ferric ammonium citrate anticaking agent

232. 383 Calcium glycerophosphate Thickener, gelling agent, Stabilizer

233. 384 Isopropyl citrates Antioxidant, Preservative, Sequestrant

234. 385 Calcium disodium ethylene- diamine-tetra-acetate

Antioxidant, Preservative, Sequestrant

235. 386 Disodium ethylene-diamine-tetraacetate Antioxidant, Preservative, Sequestrant

236. 387 Oxy stearin Antioxidant, sequestrant

237. 388 Thiodipropionic acid Antioxidant

238. 389 Dilauryl thiodipropionate Antioxidant

239. 390 Distearyl thiodipropionate Antioxidant

240. 391 Phytic acid Antioxidant

241. 399 Calcium lactobionate Stabilizer

242. 400 Alginic acid Thickener, stabilizer

243. 401 Sodium alginate Thickener, stabilizer, gelling Agent

244. 402 Potassium alginate Thickener, stabilizer

245. 403 Ammonium alginate Thickener, stabilizer

246. 404 Calcium alginate Thickener, stabilizer, gelling Agent, antifoaming agent

247. 405 Propylene glycol alginate Thickener, emulsifier

248. 406 Agar Thickener, gelling agent, Stabilizer

249. 407 Carrageenan and its Na, K, NH4 salts (includes furcellaran)

Thickener, gelling agent, Stabilizer

250. 407a Processed Euchema Seaweed (PES) Thickener, stabilizer

251. 408 Bakers yeast glycan Thickener, gelling agent, Stabilizer

252. 409 Arabinogalactan Thickener, gelling agent, Stabilizer

253. 410 Carob bean gum Thickener, Stabilizer

254. 411 Oat gum Thickener, Stabilizer

255. 412 Guar gum Thickener, Stabilizer, Emulsifier

256. 413 Tragacanth gum Thickener, Stabilizer, Emulsifier

257. 414 Gum arabic (acacia gum) Thickener, Stabilizer

258. 415 Xanthan gum Thickener, Stabilizer, emulsifier, foaming agent

259. 416 Karaya gum Thickener, Stabilizer

260. 417 Tara gum Thickener, Stabilizer

261. 418 Gellan gum Thickener, Stabilizer, gelling Agent

262. 419 Gum ghatti Thickener, Stabilizer, Emulsifier

263. 420 Sorbitol and sorbitol syrup Sweetener, Humectant, sequestrant, Texturizer, Emulsifier

264. 421 Mannitol Sweetener, anticaking agent

265. 422 Glycerol Humectant, bodying agent

266. 424 Curd lan Thickener, Stabilizer

Page 283: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

692 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

267. 425 Konjac flour Thickener

268. 429 Peptones Emulsifier

269. 430 Polyoxyethylene (8) stearate Emulsifier

270. 431 Polyoxyethylene (40) stearate Emulsifier

271. 432 Polyoxyethylene (20) sorbitan Monolaurate Emulsifier, dispersing agent

272. 433 Polyoxyethylene (20) sorbitan Monoleate Emulsifier, dispersing agent

273. 434 Polyoxyethylene (20) sorbitan Monopalmitate

Emulsifier, dispersing agent

274. 435 Polyoxyethylene (20) sorbitan Monostearate

Emulsifier, dispersing agent

275. 436 Polyoxyethylene (20) sorbitan Tristearate Emulsifier, dispersing agent

276. 440 Pectins Thickener, emulsifier, Stabilizer, gelling agent

277. 441 Superglycerinated hydrogenated rapeseed oil

Emulsifier

278. 442 Ammonium salts of phosphatidic Acid Emulsifier

279. 443 Brominated vegetable oil Emulsifier, stabilizer

280. 444 Sucrose acetate isobutyrate Emulsifier, stabilizer

281. 445 Glycerol esters of wood resin Emulsifier, stabilizer

282. 446 Succistearin Emulsifier

283. 450 Diphosphates acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

284. 450(i) Disodium diphosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

285. 450(ii) Trisodium diphosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

286. 450(iii) Tetrasodium diphosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

287. 450(iv) Dipotassium diphosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

288. 450(v) Tetrapotassium diphosphate Emulsifier, Stabilizer, acidity regulator, raising agent Sequestrant, water retention Agent

289. 450(vi) Dicalcium diphosphate acidity regulator, texturizer, sequestrant stabilizer, Emulsifier, water retention Agent

290. 450(vii) Calcium dihydrogen diphosphate Emulsifier, raising agent, stabilizer, sequestrant, acidity, regulator, water retention agent

291. 450 (viii) Dimagnesium diphosphate acidity regulator, texturizer, sequestrant, stabilizer, Emulsifier, water retention Agent

292. 451 Triphosphates Sequestrant, acidity regulator Texturizer

293. 451(i) Pentasodium Sequestrant, acidity regulator, Texturizer

294. 451(ii) Pentapotassium triphosphate Sequestrant, acidity regulator, Texturizer

295. 452 Polyphosphates acidity regulator, texturizer, sequestrant stabilizer, Emulsifier, water retention Agent

296. 452(i) Sodium polyphosphate acidity regulator, texturizer, sequestrant stabilizer, Emulsifier, water retention Agent

Page 284: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 693

Sl.No. INS Number Food Additive Name Technical functions

297. 452(ii) Potassium Polyphosphate acidity regulator, texturizer, sequestrant stabilizer, Emulsifier, water retention Agent

298. 452(iii) Sodium calcium polyphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

299. 452(iv) Calcium polyphosphates Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

300. 452(v) Ammonium polyphosphates Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

301. 458 Gamma Cyclodextrin Stabilizer, binder

302. 459 Beta-cyclodextrin Stabilizer, binder

303. 460 Cellulose Emulsifier, dispersing agent, anticaking agent, texturizer

304. 460(i) Microcystalline cellulose Emulsifier, dispersing agent, anticaking agent

305. 460(ii) Powdered cellulose Emulsifier dispersing agent, anticaking agent

306. 461 Methyl cellulose Thickener, Emulsifier, Stabilizer

307. 462 Ethyl cellulose Binder, filler

308. 463 Hydroxypropyl cellulose Thickener, Emulsifier, Stabilizer

309. 464 Hydroxypropyl methyl cellulose Thickener, Emulsifier, Stabilizer

310. 465 Methyl ethyl cellulose Thickener antifoaming agent, Emulsifier, stabilizer

311. 466 Sodium carboxymethyl cellulose Thickener, Emulsifier, Stabilizer

312. 467 Ethyl hydroxyethyl cellulose Thickener, Emulsifier, Stabilizer

313. 468 Croscaramellose Stabilizer, binder

314. 469 Sodium carboxymethyl cellulose, enzymatically hydrolysed

Thickener, stabilizer

315. 470 Salts of fatty acids (with base Al, Ca, Na, Mg, K, and NH4)

Emulsifier, Stabilizer, anticaking agent

316. 471 Mono-and di-glycerides of fatty acids Emulsifier, Stabilizer

317. 472a Acetic and fatty acid esters of glycerol Emulsifier, Stabilizer Sequestrant

318. 472b Lactic and fatty acid esters of glycerol Emulsifier, Stabilizer, Sequestrant

319. 472c Citric and fatty acid esters of glycerol Emulsifier, Stabilizer, Sequestrant

320. 472d Tartaric acid esters of mono and diglycerides of fatty acids

Emulsifier, Stabilizer, Sequestrant

321. 472e Diacetyltartric and fatty acid ester of glycerol

Emulsifier, Stabilizer, Sequestrant

322. 472f Mixed tartaric, acetic and fatty acid esters of glycerol

Emulsifier, Stabilizers, Sequestrant

323. 472g Succinylated monoglycerides Emulsifier, Stabilizer, Sequestrant

324. 473 Sucrose esters of fatty acids Emulsifier, Stabilizer, Sequestrant

325. 474 Sucroglycerides Emulsifier, Stabilizer, Sequestrant

326. 475 Polyglycerol esters of fatty acid Emulsifier, Stabilizer, Sequestrant

327. 476 Polyglycerol esters of interesteri- fied ricinoleic acid

Emulsifier, Stabilizer, Sequestrant

328. 477 Propylene glycol esters of fatty Acids Emulsifier, Stabilizer, Sequestrant

329. 478 Lactylated fatty acid esters of glycerol and propylene glycol

Emulsifier, Stabilizer, Sequestrant

Page 285: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

694 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

330. 479. Thermally oxidized soya bean oil with mono-and di-glycerides of fatty acids

Emulsifier, Stabilizer, Sequestrant

331. 480 Dioctyl sodium sulphosuccinate Emulsifier, wetting agent

332. 481 Sodium lactylate Emulsifier, Stabilizer

333. 481(i) Sodium stearoyl lactylates Emulsifier, Stabilizer

334. 481(ii) Sodium oleyl lactylate Emulsifier, Stabilizer

335. 482 Calcium lactylates Emulsifier, Stabilizer

336. 482(i) Calcium stearoyl lactylate Emulsifier, Stabilizer

337. 482(ii) Calcium oleyl lactylates Emulsifier, Stabilizer

338. 483 Stearyl tartrate Flour treatment agent

339. 484 Stearyl citrate Emulsifier, sequestrant

340. 485 Sodium stearoyl fumarate Emulsifier

341. 486 Calcium stearoyl fumarate Emulsifier

342. 487 Sodium laurylsulphate Emulsifier

343. 488 Ethoxylated mono-and di-glycerides Emulsifier

344. 489 Methyl glucoside-coconut oil ester Emulsifier

345. 491 Sorbitan monostearate Emulsifier

346. 492 Sorbitan tristearate Emulsifier

347. 493 Sorbitan monolaurate Emulsifier

348. 494 Sorbitan monooleate Emulsifier

349. 495 Sorbitan monopalmitate Emulsifier

350. 496 Sorbitan trioleate Stabilizer, Emulsifier

351. 500 Sodium carbonates acidity regulator, raising agent, anticaking agent

352. 500(i) Sodium carbonate acidity regluator, raising agent, anticaking agent

353. 500(ii) Sodium hydrogen carbonate acidity regulator, raising agent, anticaking agent

354. 500(iii) Sodium sesquicarbonate acidity regulator, raising agent, anticaking agent

355. 501 Potassium carbonates acidity regulator, stabilizer

356. 501(i) Potassium carbonate acidity regulator, stabilizer

357. 501(ii) Potassium hydrogen carbonate acidity regulator, stabilizer

358. 503 Ammonium carbonates acidity regulator, raising agent

359. 503(i) Ammonium carbonate acidity regulator, raising agent

360. 503(ii) Ammonium hydrogen carbonate acidity regulator, raising agent

361. 504 Magnesium carbonates acidity regulator, anticaking agent, colour retention agent

362. 504(i) Magnesium carbonate acidity regulator, anticaking agent, colour retention agent

363. 504(ii) Magnesium hydrogen carbonate acidity regulator, anticaking agent, colour retention agent

364. 505 Ferrous carbonate acidity regulator

365. 507 Hydrochloric acid acidity regulator acid

366. 508 Potassium chloride gelling agent

367. 509 Calcium chloride firming agent

368. 510 Ammonium chloride flour treatment agent

Page 286: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 695

Sl.No. INS Number Food Additive Name Technical functions

369. 511 Magnesium chloride firming agent

370. 512 Stannous chloride Antioxidant, colour retention Agent

371. 513 Sulphuric acid acidity regulator

372. 514 Sodium sulphates acidity regulator

373 515 Potassium sulphates Acidity regulator

374. 516 Calcium Sulphate Dough conditioner, Sequestrant, firming agent

375. 517 Ammonium sulphate Flour treatment agent, stabilizer

376. 518 Magnesium sulphate firming agent

377. 519 Cupric sulphate colour fixative, preservative

378. 520 Aluminium sulphate firming agent

379. 521 Aluminium sodium Sulphate firming agent

380. 522 Aluminium potassium Sulphate Acidity regulator, stabilizer

381. 523 Aluminium ammonium Sulphate Stabilizer, firming agent

382. 524 Sodium hydroxide acidity regulator

383. 525 Potassium hydroxide acidity regulator

384. 526 Calcium hydroxide acidity regulator, firming agent

385. 527 Ammonium hydroxide acidity regulator

386. 528 Magnesium hydroxide acidity regulator, colour retention agent

387. 529 Calcium oxide acidity regulator, colour retention agent

388. 530 Magnesium oxide anticaking agent

389. 535 Sodium ferrocyanide anticaking agent

390. 536 Potassium ferrocyanide anticaking agent

391. 537 Ferrous hexacyanomanganate anticaking agent

392. 538 Calcium ferrocyanide anticaking agent

393. 539 Sodium thiosulphate antioxidant, sequestrant

394. 541 Sodium aluminium phosphate acidity regulator, emulsifier

395. 541(i) Sodium aluminium phosphate-acidic acidity regulator, emulsifier

396. 541(ii) Sodium aluminium phosphate-basic acidity regulator, emulsifier

397. 542 Bone phosphate (essentially calcium phosphate, tribasic)

Emulsifier, anticaking agent, water retention agent

398. 550 Sodium silicates anticaking agent

399. 550(i) Sodium silicate anticaking agent

400. 550(ii) Sodium metasilicate anticaking agent

401. 551 Silicon dioxide, amorphous anticaking agent

402. 552 Calcium silicate anticaking agent

403. 553 Magnesium silicates anticaking agent, dusting Powder

404. 553(i) Magnesium silicate anticaking agent, dusting Powder

405. 553(ii) Magnesium trisilicate anticaking agent, dusting Powder

406. 553(iii) Talc anticaking agent, dusting Powder

407. 554 Sodium aluminosilicate anticaking agent

408. 555 Potassium aluminium silicate anticaking agent

409. 556 Calcium aluminium silicate anticaking agent

Page 287: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

696 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

410. 557 Zinc silicate anticaking agent

411. 558 Bentonite anticaking agent

412. 559 Aluminium silicate anticaking agent

413. 560 Potassium silicate anticaking agent

414. 570 Fatty acids foam stabilizer, glazing agent, antifoaming agent

415. 574 Gluconic acid (D-) acidity regulator, raising agent

416. 575 Glucono delta-lactone acidity regulator, raising agent

417. 576 Sodium gluconate Sequestrant

418. 577 Potassium gluconate Sequestrant

419. 578 Calcium gluconate acidity regluator, firming agent

420. 579 Ferrous gluconate Colour retention agent

421. 580 Magnesium gluconate acidity regulator, firming agent

422. 585 Ferrous lactate colour retention agent

423. 586 4-Hexylresorcinol colour retention agent, Antioxidant

424. 620 Glutamic acid (L (+)-) flavour enhancer

425. 621 Monosodium glutamate flavour enhancer

426. 622 Monopotassium glutamate flavour enhancer

427. 623 Calcium glutamate flavour enhancer

428. 624 Monoammonium glutamate flavour enhancer

429. 625 Magnesium glutamate flavour enhancer

430. 626 Guanylic acid flavour enhancer

431. 627 Disodium 5'-guanylate flavour enhancer

432. 628 Dipotassium 5'-guanylate flavour enhancer

433. 629 Calcium 5'-guanylate flavour enhancer

434. 630 Inosinic acid flavour enhancer

435. 631 Disodium 5'-inosinate flavour enhancer

436. 632 Potassium Inosate flavour enhancer

437. 633 Calcium 5'-inosinate flavour enhancer

438. 634 Calcium 5'-ribonucleotides flavour enhancer

439. 635 Disodium 5'-ribonucleotides flavour enhancer

440. 636 Maltol flavour enhancer

441. 637 Ethyl maltol flavour enhancer

442. 638 Sodium L-Aspartate flavour enhancer

443. 639 DL-Alanine flavour enhancer

444. 640 Glycine flavour enhancer

445. 641 L-Leucine flavour enhancer

446. 642 Lysin hydrochloride flavour enhancer

447. 900a Polydimethylsiloxane antifoaming agent, anticaking agent, emulsifier

448. 900b Methylphenylpolysiloxane antifoaming agent

449. 901 Beeswax, white and yellow glazing agent, release agent

450. 902 Candeilla Wax glazing agent

Page 288: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 697

Sl.No. INS Number Food Additive Name Technical functions

451. 903 Carnaubawax glazing agent

452. 904 Shellac glazing agent

453. 905a Mineral oil, food grade glazing agent, release agent sealing agent

454. 905b Petrolatum Petroleumielly glazing agent, release agent, sealing agent

455. 905c Petroleum wax glazing agent, release agent, sealing agent

456. 905c(i) Microcrystallinewax glazing agent

457. 905c(ii) Paraffin wax glazing agent

458. 906 Benzoin gum glazing agent

459. 907 Hydrogenated poly-1 decene glazing agent

460. 908 Rice bran wax glazing agent

461. 909 Spermaceti wax glazing agent

462. 910 Wax esters glazing agent

463. 911 Methyl esters of fatty acids glazing agent

464. 913 Lanolin glazing agent

465. 915 Glycerol-, methyl-, or penta- erithrytol esters of colophane

glazing agent

466. 916 Calcium iodate flour treatment agent

467. 917 Potassium iodate flour treatment agent

468. 918 Nitrogen oxide flour treatment agent

469. 919 Nitrosyl chloride flour treatment agent

470. 920 L-Cysteine and its hydrochlorides- sodium and potassium salts

flour treatment agent

471. 921 L-Cysteine and its hydrochlorides- sodium and potassium salts

flour treatment agent

472. 922 Potassium persulphate flour treatment agent

473. 923 Ammonium persulphate flour treatment agent

474. 924a Potassium bromate flour treatment agent

475. 924b Calcium bromate flour treatment agent

476. 925 Chlorine flour treatment agent

477. 926 Chlorine dioxide flour treatment agent

478. 927a Azodicarbonamide flour treatment agent

479. 927b Carbamide (urea) flour treatment agent

480. 928 Benzoyl peroxide flour treatment agent, Preservative

481. 929 Acetone peroxide flour treatment agent

482. 930 Calcium peroxide flour treatment agent

483. 938 Argon packing gas

484. 939 Helium packing gas

485. 940 Dichlorodifluoromethane Propellant, liquid freezant

486. 941 Nitrogen Packing gas, freezant

487. 942 Nitrous oxide Propellant

488. 943a Butane Propellant

489. 943b Isobutane Propellant

Page 289: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

698 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl.No. INS Number Food Additive Name Technical functions

490. 944 Propane Propellant

491. 945 Chloropentafluoroethane Propellant

492. 946 Octafluorocyclobutane Propellant

493. 948 Oxygen packing gas

494. 950 Acesulfame potassium Sweetener, flavour enhancer

495. 951 Aspartame Sweetener, flavour enhancer

496. 952 Cyclamic acid (and Na, K, Ca Salts) Sweetener

497 953 Isomalt (isomaltitol) Sweetener, anticaking agent, bulking agent, glazing agent

498. 954 Saccharin (and Na, K, Ca salts) Sweetener

499. 955 Sucralose (trichlorogalactosucrose) Sweetener

500. 956 Alitame Sweetener

501. 957 Thaumatin Sweetener, flavour enhancer

502. 958 Glycyrrhizin Sweetener, flavour enhancer

503. 959 Neohesperidine dihydrochalcone Sweetener

504. 960 Stevioside Sweetener

505. 964 Polyglycitol syrup Sweetener

506. 965 Maltitol and matitol Syrup Sweetener, stabilizer, emulsifier

507. 966 Lactitol Sweetener, texturizer

508. 967 Xylitol Sweetener, humectant, stabilizer, Emulsifier, thickener

509. 968 Erythritol Sweetener, flavour enhancer, Humectant

510. 999 Qulillaia extracts foaming agent

511. 1000 Cholic acid Emulsifier

512. 1001 Choline salts and esters Emulsifier

513. 1001(i) Choline acentate Emulsifier

514. 1001(ii) Choline carbonate Emulsifier

515. 1001(iii) Choline chloride Emulsifier

516. 1001(iv) Choline citrate Emulsifier

517. 1001(v) Choline tartrate Emulsifier

518. 1001(vi) Choline lactate Emulsifier

519. 1100 Amylases flour treatment agent

520. 1101 Proteases flour treatment agent, stabilizer, tenderizer, flavour enhancer

521. 1101(i) Protease flour treatment agent, stabilizer, tenderizer, flavour enhancer

522 1101(ii) Papain flour treatment agent, stabilizer, tenderizer, flavour enhancer

523 1101(iii) Bromelain flour treatment agent, stabilizer, tenderizer, flavour enhancer

524 1101(iv) Ficin flour treatment agent, stabilizer, tenderizer, flavour enhancer

525 1102 Glucose oxidase Antioxidant

Page 290: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 699

Sl.No. INS Number Food Additive Name Technical functions

526 1103 Invertases Stabilizer

527 1104 Lipases flavour enhancer

528 1105 Lysozyme Preservative

529 1200 Polydextroses A and N bulking agent, stabilizer, thickener, Humectant texturizer

530 1201 Polyvinylpyrrolidone bodying agent, stabilizer, clarifying agent, dispersing Agent

531 1202 Polyvinylpolypyrrolidone colour stabilizer, colloidal, Stabilizer

532 1503 Castor oil release agent

533 1505 Triethyl citrate foam stabilizer

534 1518 Triacetin Humectant

535 1520 Propylene glycol Humectant, Wetting agent, dispersing agent

536 1521 Polyethylene glycol antifoaming agent

Supplementary List-Modified Starches

537 1400 Dextrins, roasted starch white and yellow Stabilizer, thickener, binder

538 1401 Acid-treated starch Stabilizer, thickener, binder

539 1402 Alkaline treated starch Stabilizer, thickener, binder

540 1403 Bleached starch Stabilizer, thickener, binder

541 1404 Oxidised starch Stabilizer, thickener, binder

542 1405 Starches, enzyme-treated Thickener

543 1410 Monostarch phosphate Stabilizer, thickener, binder

544 1411 Distarch glycerol Stabilizer, thickener, binder

545 1412 Distarch phosphate esterified with sodium trimetaphosphate;

Stabilizer, thickener, binder

546 1413 Phosphated distarch phosphate Stabilizer, thickener, binder

547 1414 Acetylated distarch phosphate Emulsifier, thickener, binder

548 1420 Starch acetate esterified with Acetic anhydride

Stabilizer, thickener

549 1421 Starch acetate esterified with vinyl acetate Stabilizer, thickener

550 1422 Acetylated distarch adipate Stabilizer, thickener, binder, Emulsifier

551 1423 Acetylated distarch glycord Stabilizer, thickener

552 1440 Hydroxypropyl starch Stabilizer, thickener, binder, Emulsifier

553 1442 Hydroxypropyl distarch phosphate Stabilizer, thickener

554 1443 Hydroxypropyl distarch Stabilizer, thickener

555 1450 Starch sodium octenyl succinate Stabilizer, thickener, binder

Page 291: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

700 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

B. List sorted by alphabetical Order-International Numbering System (INS) for Food Additives

The following list sorted by alphabetical order alongwith INS No. is only for identifying the INS No. of these food additives or their synonyms as per Codex. These are the list of food additive as per Codex and the food additives allowed under the Food Safety and Standards Regulations, 2010 are listed in these including Appendices

The list given below as published by Codex as on date (23-11-2005). For any revision JECFA/Codex website may be referred (www.codexalimentarius.net; www.codexalimentarius.net/web/jecfa.jsp)

Sl. No. INS Number Food Additive Name Technical functions

1. 370 1,4-Heptonolactone acidity regulator, sequestrant

2. 586 4-Hexylresorcinol colour retention agent, Antioxidant

3. 950 Acesulfame potassium Sweetener, flavour enhancer

4. 260 Acetic acid, glacial Preservative, acidity regulator

5. 472a Acetic and fatty acid esters of Glycerol Emulsifier, Stabilizer, Sequestrant

6. 929 Acetone peroxide flour treatment agent

7. 355 Adipic acid Acidity regulator

8. 406 Agar Thickener, gelling agent, Stabilizer

9. 400 Alginic acid Thickener, stabilizer

10. 956 Alitame Sweetener

11. 103 Alkanet Colour

12. 129 Allurared AC Colour

13. 307 Alpha-tocopherol Antioxidant

14. 173 Aluminium Colour

15. 523 Aluminium ammonium sulphate Stabilizer, firming agent

16. 522 Aluminium potassium sulphate acidity regulator, stabilizer

17. 559 Aluminium sodium silicate anticaking agent

18. 521 Aluminium sodium sulphate firming agent

19. 520 Aluminium sulphate firming agent

20. 123 Amaranth Colour

21. 264 Ammonium acetate Acidity regulator

22. 359 Ammonium adipates Acidity regulator

23. 403 Ammonium alginate Thickener, stabilizer

24. 503(i) Ammonium carbonate acidity regulator, raising agent

25. 503 Ammonium carbonates acidity regulator, raising agent

26. 510 Ammonium chloride flour treatment agent

27. 380 Ammonium citrates Acidity regulator

28. 368 Ammonium fumarate Acidity regulator

29. 503(ii) Ammonium hydrogen carbonate acidity regulator, raising agent

30. 527 Ammonium hydroxide Acidity regulator

31. 328 Ammonium lactate acidity regulator, flour treatment agent

32. 349 Ammonium malate Acidity regulator

33. 923 Ammonium persulphate flour treatment agent

34. 342 Ammonium phosphates acidity regulator, flour treatment agent

35. 452(v) Ammonium polyphosphates emulsifier raising agent, stabilizer sequestrant, Acidity regulator, water retention agent

Page 292: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 701

Sl. No. INS Number Food Additive Name Technical functions

36. 442 Ammonium salts of phosphatidic Acid Emulsifier

37. 517 Ammonium sulphate flour treatment agent, stabilizer

38. 1100 Amylases flour treatment agent

39. 160b Annatto extracts Colour

40. 323 Anoxomer Antioxidant

41. 163(i) Anthocyanins Colour

42. 163 Anothocyanins Colour

43. 409 Arabinogalactan Thickener, gelling agent, Stabilizer

44. 938 Argon packing gas

45. 300 Ascorbic acid(L-) Antioxidant

46. 304 Ascorbyl palmitate Antioxidant

47. 305 Ascorbyl stearate Antioxidant

48. 951 Aspartame Sweetener, flavour enhancer

49. 927a Azodicarbonamide flour treatment agent

50. 122 Azorubine Colour

51. 408 Bakers yeast glycan Thickener, gelling agent, Stabilizer

52. 901 Beeswax, white and yellow glazing agent, release agent

53. 162 Beet red Colour

54. 558 Bentonite anticaking agent

55. 210 Benzole acid Preservative

56. 906 Benzoin gum glazing agent

57. 928 Benzoyl peroxide flour treatment agent, Preservative

58. 160 f Beta-apo-8’carotenic acid, methyl or enthyl ester Colour

59. 160e Beta-apo-Carotenal Colour

60. 160a(i) Beta-Carotene (Synthetic) Colour

61. 459 Beta-cyclodextrin Stabilizer, binder

62. 163(iii) Blackcurrant extract Colour

63. 542 Bone phosphate (essentially calcium phosphate, tribasic)

Emulsifier, anticaking agent, water retention agent

64. 151 Brilliant black PN Colour

65. 133 Brilliant blue FCF Colour

66. 1101(iii) Bromelain flour treatment agent, stabilizer, tenderizer, flavour enhancer

67. 443 Brominated vegetable oil Emulsifier, stabilizer

68. 154 Brown FK Colour

69. 155 Brown HT Colour

70. 943a Butane Propellant

71. 320 Butylated hydroxyanisole Antioxidant

72. 321 Butylated hydroxytoluene Antioxidant

73. 629 Calcium 5'-guanylate flavour enhancer

74. 633 Calcium 5' -inosinate flavour enhancer

75. 634 Calcium 5' -ribonucleotides flavour enhancer

Page 293: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

702 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

76. 263 Calcium acetate Preservative, stabilizer, acidity Regulator

77. 404 Calcium alginate Thickener, Stabilizer, gelling agent, antifoaming agent

78. 556 Calcium aluminium silicate anticaking agent

79. 302 Calcium ascorbate Antioxidant

80. 213 Calcium benzoate Preservative

81. 924 b Calcium bromate flour treatment agent

82. 170(i) Calcium carbonate anticaking agent

83. 170 Calcium carbonate Surface colourant, anticaking agent, stabilizer

84. 509 Calcium chloride firming agent

85. 333 Calcium citrates acidity regulator, firming agent, Sequestrant

86. 450 (vii) Calcium dihydrogen diphosphate emulsifier, raising agent, stabilizer sequestrant, acidity regulator water retention agent

87. 385 Calcium disodium ethylene- diamine-tetra-acetate Antioxidant, Preservative, Sequestrant

88. 538 Calcium ferrocyanide anticaking agent

89. 238 Calcium formate Preservative

90. 367 Calcium fumarates Acidity regulator

91. 578 Calcium gluconate acidity regulator, firming agent

92. 623 Calcium glutamate flavour enhancer

93. 383 Calcium Thickener, gelling agent, Stabilizer

94. 170 (ii) Calcium hydrogen carbonate anticaking agent

95. 352 (i) Calcium hydrogen malate Acidity regulator

96. 227 Calcium hydrogen Preservative, antioxidant

97. 526 Calcium hydroxide acidity regulator, firming agent

98. 916 Calcium iodate flour treatment agent

99. 318 Calcium isoascorbate Antioxidant

100. 327 Calcium lactate acidity regulator, flour treatment agent

101. 399 Calcium lactobionate Stabilizer

102. 482 Calcium lactylates Emulsifier, stabilizer

103. 352 (ii) Calcium malate Acidity regulator

104. 352 Calcium malates Acidity regulator

105. 482 (ii) Calcium oleyl lactylate Emulsifier, stabilizer

106. 529 Calcium oxide acidity regulator, colour retention agent

107. 930 Calcium peroxide flour treatment agent

108. 341 Calcium phosphates acidity regulator, flour treatment agent, firming agent, Texturizer, raising agent, anticaking agent, water retention agent

109. 452 (iv) Calcium polyphosphates Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

110. 282 Calcium propionate Preservative

Page 294: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 703

Sl. No. INS Number Food Additive Name Technical functions

111. 552 Calcium silicate anticaking agent

112. 203 Calcium sorbate Preservative

113. 486 Calcium stearoyl fumarate Emulsifier

114. 482 (i) Calcium stearoyl lactylate Emulsifier, stabilizer

115. 516 Calcium sulphate flour treatment agent, Sequestrant, firming agent

116. 226 Calcium sulphite preservative, antioxidant

117. 354 Calcium tartrate Acidity regulator

118. 902 Candelilla wax glazing agent

119. 161 g Canthaxanthin Colour

120. 150a Caramel I-plain Colour

121. 150 b Caramel II-caustic sulphite process Colour

122. 150 c Caramel III-ammonia process Colour

123. 150 d Caramel IV-ammonia sulphite process Colour

124. 927 b Carbamide (urea) flour treatment agent

125. 152 Carbon black (hydrocarbon) Colour

126. 290 Carbon dioxide carbonating agent, packing gas

127. 120 Carmines Colour

128. 903 Carnaubawax glazing agent

129. 410 Carob bean gum Thickener, stabilizer

130. 160a Carotenes Colour

131. 407 Carrageenan and its Na, K, Thickener, gelling agent,

NH4 salts (includes furcellaran) Stabilizer

132. 1503 Castor oil release agent

133. 460 Cellulose Emulsifier, anticaking agent, texturizer, dispersing agent

134. 925 Chlorine flour treatment agent

135. 926 Chlorine dioxide flour treatment agent

136. 945 Chloropentafluoroethane Propellant

137. 140 Chlorophyll Copper Colour

138. 141(i) Chlorophyll copper complex Colour

139. 141(ii) Chlorophyll copper complex sodium and potassium Salts

Colour

140. 1000 Cholic acid Emulsifier

141. 1001(i) Choline acetate Emulsifier

142. 1001(ii) Choline carbonate Emulsifier

143. 1001(iii) Choline chloride Emulsifier

144. 1001(iv) Choline citrate Emulsifier

145. 1001(vi) Choline lactate Emulsifier

146. 1001 Choline salt and esters Emulsifier

147. 1001(v) Choline tartrate Emulsifier

148. 330 Citric acid acidity regulator, Antioxidant, Sequestrant

Page 295: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

704 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

149. 472 c Citric and fatty acid esters of glycerol Emlsifier, Stabilizer, Sequestrant

150. 121 Citrus red 2 Colour

151. 141 Copper chlorophylls Colour

152. 468 Croscaramellose Stabilizer, binder

153. 519 Cupric sulphate colour fixture, preservative

154. 100(i) Curcumin Colour

155. 100 Curcumins Colour

156. 424 Curdlan Thickener, stabilizer

157. 952 Cyclamic acid (and Na, K, Ca Salts) Sweetener

158. 265 Dehydroacetic acid Preservative

159. 472e Diacetyltartaric and fatty acid esters of glycerol Emulsifier, Stabilizer, Sequestrant

160. 342(ii) Diammonium orthophosphate acidity regulator, flour treatment agent

161. 450 (vi) Dicalcium diphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

162. 341(ii) Dicalcium orthophosphate acidity regulator, flour treatment agent, firming agent, Texturizer

163. 940 Dichlorodifluoromethane Propellant, liquid freezant

164. 389 Dilauryl thiodipropionate Antioxidant

165. 450 (viii) Dimagnesium diphosphate emulsifier raising agent, stabilizer sequestrant, acidity regulator, water retention agent

166. 343(ii) Dimagnesium acidity regulator, anticaking Agent

167. 242 Dimethyl dicarbonate Preservative

168. 480 Dioctyl sodium sulphosuccinate Emulsifier, wetting agent

169. 230 Diphenyl Preservative

170. 450 Diphosphates Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

171. 628 Dipotassium 5'-guanylate flavour enhancer

172. 450(iv) Dipotassium diphosphate Emulsifier, Stabilizer, acidity, regulator, raising agent, Sequestrant, water retention Agent

173. 340(ii) Dipotassium orthophosphate acidity regulator texturizer, sequestrant, stabilizer, emulsifier water retention agent

174. 336(ii) Dipotassium tartrate Stabilizer, sequestrant

175. 627 Disodium 5'-guanylate flavour enhancer

176. 631 Disodium 5'-inosinate flavour enhancer

177. 635 Disodium 5'-ribonucleotides flavour enhancer

178. 450(i) Disodium diphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

179. 386 Disodium ethylene-diamine-tetra -acetate Antioxidant, Preservative, Sequestrant

180. 331(ii) Disodium monohydrogen citrate acidity regulator, stabilizer, Sequestrant, emulsifier

Page 296: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 705

Sl. No. INS Number Food Additive Name Technical functions

181. 339(ii) Disodium orthophosphate acidity regulator, Sequestrant, emulsifier, Texturizer, Stabilizer, water retention agent

182. 335(ii) Disodium tartrate Stabilizer, sequestrant

183. 364(ii) Disodium succinate acidity regulator, flavour Enhancer

184. 390 Distearyl thiodipropionate Antioxidant

185. 639 DL-Alanine flavour enhancer

186. 312 Dodecyl gallate Antioxidant

187. 968 Erythritol Sweetener, flavour enhancer, Humectant

188. 127 Erythrosine Colour

189. 488 Ethoxylated mono-and di-glycerides Emulsifier

190. 324 Ethoxyquin Antioxidant

191. 462 Ethyl cellulose Binder, filler

192. 313 Ethyl gallate Antioxidant

193. 467 Ethyl hydroxyethyl cellulose Thickener, emulsifier, stabilizer

194. 637 Ethyl maltol flavour enhancer

195. 214 Ethyl-p-hydroxybenzoate Preservative

196. 143 Fast green FCF Colour

197. 570 Fatty acids foam stabilizer, glazing agent, antifoaming agent

198. 381 Ferric ammonium citrate anticaking agent

199. 505 Ferrous carbonate Acidity regulator

200. 579 Ferrous gluconate Colour retention agent

201. 537 Ferrous hexacyanomanganate anticaking agent

202. 585 Ferrous lactate Colour retention agent

203. 1101(iv) Ficin flour treatment agent, stabilizer, tenderizer, flavour enhancer

204. 161a Flavoxanthin Colour

205. 240 Formaldehyde Preservative

206. 236 Formic acid Preservative

207. 297 Fumaric acid Acidity regulator

208. 458 Gamma Cyclodextrin Stabilizer, binder

209. 164 Gardenia yellow Colour

210. 418 Gellan gum Thickener, stabilizer, gelling Agent

211. 574 Gluconic acid (D-) acidity regulator, raising agent

212. 575 Glucono delta-lactone acidity regulator, raising agent

213. 1102 Glucose oxidase Antioxidant

214. 620 Glutamic acid (L(+)-) flavour enhancer

215. 422 Glycerol Humectant, bodying agent

216. 445 Glycerol esters of wood resin Emulsifier, stabilizer

217. 915 Glycerol-, methyl-, or penta- erithrytol esters of colophane

Glazing agent

218. 640 Glycine Flavour modifier

Page 297: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

706 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

219. 958 Glycyrrhizin Sweetener, flavour enhancer

220. 175 Gold Colour

221. 163 (ii) Grape skin extract Colour

222. 142 Green S Colour

223. 314 Guaiac resin Antioxidant

224. 626 Guanlic acid flavour enhancer

225. 412 Guar gum Thickener, stabilizer

226. 414 Gum arabic (acacia gum) Thickener, stabilizer

227. 419 Gum ghatti Thickener, stabilizer, emulsifier

228. 241 Gum guaicum Preservative

229. 939 Helium packing gas

230. 209 Heptyl-p-hydroxybenzoate Preservative

231. 239 Hexamethylene tetramine Preservative

232. 507 Hydrochloric acid Acidity regulator

233. 907 Hydrogenated poly-1-decene glazing agent

234. 463 Hydroxypropyl cellulose Thickener, Emulsifier, Stabilizer

235. 464 Hydroxypropyl methyl cellulose Thickener, Emulsifier, Stabilizer

236. 132 Indigotine Colour

237. 630 Inosinic acid flavour enhancer

238. 1103 Invertases Stabilizer

239. 172 (i) Iron oxide, black Colour

240. 172(ii) Iron oxide, red Colour

241. 172(iii) Iron oxide, yellow Colour

242. 172 Iron oxides Colour

243. 315 Isoascorbic acid Antioxidant

244. 943b Isobutane Propellant

245. 953 Isomalt (isomaltitol) Sweetener, anticaking agent, bulking agent, glazing agent

246. 384 Isopropyl citrates Antioxidant, Preservative, Sequestrant

247. 416. Karaya gum Thickener, stabilizer

248. 425 Lonjac flour Thickener

249. 161c Kryptoxanthin Colour

250. 920 L-Cysteine and its hydrochlorides- sodium and potassium salts

flour treatment agent

251. 921 L-Cysteine and its hydrochlorides- sodium and potassium salts

flour treatment agent

252. 641 L-Leucine flavour modifier.

253. 270 Lactic acid (L-, D- and Dl-) Acidity regulator

254. 472b Lactic and fatty acid esters of glycerol Emulsifier, stabilizer,

255. 966 Lactitol Sweetener, texturizer

256. 478 Lactylated fatty acid esters of glycerol and propylene glycol

Emulsifier

257. 913 Lanolin glazing agent

Page 298: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 707

Sl. No. INS Number Food Additive Name Technical functions

258. 344 Lecithin citrate Preservative

259. 322 Lecithins Antioxidant, emulsifier

260. 1104 Upases flavour enhancer

261. 180 Lithol rubine BK Colour

262. 161b Lutein Colour

263. 160d Lucopene Colour

264. 642 Lysin hydrochloride flavour enhancer

265. 1105 Lysozyme Preservative

266. 504(i) Magnesium carbonate acidity regulator, anticaking agent, colour retention agent

267. 504 Magnesium carbonates acidity regulator, anticaking agent, colour retention agent

268. 511 Magnesium chloride firming agent

269. 345 Magnesium citrate Acidity regulator

270. 580 Magnesium gluconate acidity regulator, firming agent

271. 625 Magnesium glutamate flavour enhancer

272. 504(ii) Magnesium hydrogen carbonate acidity regulator, anticaking agent, colour retention agent

273. 528 Magnesium hydroxide acidity regulator, colour retention agent

274. 329 Magnesium lactate (D-, L-) acidity regulator, flour treatment agent

275. 530 Magnesium oxide anticaking agent

276. 343 Magnesium phosphates acidity regulator, anticaking Agent

277. 553(i) Magnesium silicate anticaking agent, dusting Powder

278. 553 Magnesium Silicates anticaking agent, dusting Powder

279. 518 Magnesium sulphate firming agent

280. 553(ii) Magnesium trisilicate anticaking agent, dusting Powder

281. 296 Malic acid (D-,L-) acidity regulator, flavouring Agent

282. 965 Maltitol and maltitol Syrup Sweetener, Stabilizer, Emulsifier

283. 636 Maltol flavour enhancer

284. 130 Manascorubin Colour

285. 421 Mannitol Sweetener, anticaking agent

286. 353 Metatartaric acid Acidity regulator

287. 461 Methyl cellulose Thickener, Emulsifier, Stabilizer

288. 911 Methyl esters of fatty acids glazing agent

289. 465 Methyl ethyl cellulose Thickener, Emulsifier, stabilizer, antifoaming agent

290. 489 Methyl glucoside-coconut oil ester Emulsifier

291. 218 Methyl p-hydroxybenzoate Preservative

292. 900 b Methylphenylpolysiloxane antifoaming agent

293. 460(i) Microcrystalline cellulose Emulsifier, anticaking agent, texturizer, dispersing agent

294. 905 c (i) Microcrystalline wax glazing agent

295. 905a Mineral oil, food grade glazing agent, release agent, sealing agent

Page 299: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

708 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

296. 472 f Mixed tartaric, acetic and fatty acid esters of glycerol

Emulsifier, Stabilizer, Sequestrant

297. 306 Mixed tocopherols concentrate Antioxidant

298. 471 Mono-and di-glycerides of fatty acids Emulsifier, stabilizer

299. 624 Monoammonium glutamate flavour enhancer

300. 342 (i) Monoammonium orthophosphate acidity regulator, flour treatment agent

301. 341 (i) Monocalcium orthophosphate acidity regulator, texturizer, flour treatment agent, raising Agent

302. 343 (i) Monomagnesium orthophosphate acidity regulator, anticaking Agent

303. 622 Monopotassium glutamate flavour enhancer

304. 340 (i) Monopotassium orthophosphate acidity regulator texturizer, sequestrant stabilizer, emulsifier, water retention Agent

305. 336 (i) Monopotassium tartrate Stabilizer, sequestrant

306. 621 Monosodium glutamate flavour enhancer

307. 339 (i) Monosodium orthophosphate acidity regulator texturizer, sequestrant stabilizer, emulsifier, water retention Agent

308. 364 (i) Monosodium succinate acidity regulator, flavour Enhancer

309. 335 (i) Monosodium tartrate Stabilizer, sequestrant

310. 160a (ii) Natural extracts Colour

311. 959 Neohesperidine dihydrochalcone Sweetener

312. 375 Nicotinic acid Colour retention agent

313. 234 Nisin Preservative

314. 941 Nitrogen packing gas, freezant

315. 918 Nitrogen oxides flour treatment agent

316. 919 Nitrosyl chloride flour treatment agent

317. 942 Nitrous oxide Propellant

318. 411 Oat gum Thickener, stabilizer

319. 946 Octafluorocyclobutane Propellant

320. 311 Octyl gallate Antioxidant

321. 182 Orchil Colour

322. 231 Ortho-phenylphenol Preservative

323. 338 Orthophosphoric acid acidity regulator, antioxidant, Synergist

324. 948 Oxygen packing gas

325. 387 Oxy stearin Antioxidant, sequestrant

326. 1101(ii) Papain flour treatment agent, Stabilizer, tenderizer, flavour

327. 160c Paprika oleoresins Colour

328. 905 c (ii) Paraffin wax glazing agent

329. 131 Patent blue V Colour

330. 440 Pectins Thickener, Stabilizer, gelling Agent

331. 451 (ii) Pentapotassium triphosphate Sequestrant, acidity regulator, Texturizer

Page 300: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 709

Sl. No. INS Number Food Additive Name Technical functions

332. 451 (i) Pentasodium triphosphate Sequestrant, acidity regulator, Texturizer

333. 429 Peptones Emulsifier

334. 905 b Petrolatum (petroleum jelly) glazing agent, release agent, sealing agent

335. 905 c Petroleum wax glazing agent, release agent, sealing agent

336. 391 Phytic acid Antioxidant

337. 235 Pimaricin (natamycin) Preservative

338. 1200 Polydextroses A and N bulking agent, Stabilizer, thickener, Humectant, texturizer

339. 990a Polydimethylsiloxane antifoaming agent, anticaking agent, emulsifier

340. 1521 Polyethylene glycol antifoaming agent

341. 475 Polyglycerol esters of fatty acids Emulsifier

342. 476 Polyglycerol esters of interesterified Ricinoleic acid

Emulsifier

343. 964 Polyglycitol syrup Sweetener

344. 432 Polyoxyethylene (20) sorbitan monolaurate Emulsifier, dispersing agent

345. 433 Polyoxyethylene (20) sorbitan Mono-oleate Emulsifier, dispersing agent

346. 434 Polyoxyethylene (20) sorbitan monopalmitate Emulsifier, dispersing agent

347. 435 Polyoxyethylene (20) sorbitan monostearate Emulsifier, dispersing agent

348. 436 Polyoxyethylene (20) sorbitan tristearate Emulsifier, dispersing agent

349. 431 Polyoxyethylene (40) stearate Emulsifier

350. 430 Polyoxyethylene (8) stearate Emulsifier

351. 452 Polyphosphates Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

352. 1202 Polyvinylpolypyrrolidone colour stabilizer, Colloidal, Stabilizer

353. 1201 Polyvinylpyrrolidone bodying agent, Stabilizer, clarifying agent, dispersing Agent

354. 124 Ponceau 4R Colour

355. 125 Ponceau SX Colour

356. 261 (i) Potassium acetate Preservative, acidity regulator

357. 261 Potassium acetates Preservative, acidity regulator

358. 357 Potassium adipates Acidity regulator

359. 402 Potassium alginate Thickener, stabilizer

360. 555 Potassium aluminium silicate anticaking agent

361. 303 Potassium ascorbate Antioxidant

362. 212 Potassium benzoate Preservative

363. 228 Potassium bisulphite Preservative, antioxidant

364. 924 a Potassium bromate flour treatment agent

365. 501 (i) Potassium carbonate acidity regulator, stabilizer

366. 501 Potassium carbonates acidity regulator, stabilizer

367. 508 Potassium chloride Gelling agent

368. 332 Potassium citrates acidity regulator, Sequestrant, Stabilizer

Page 301: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

710 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

369. 261 (ii) Potassium diacetate Preservative, acidity regulator

370. 332 (i) Potassium dihydrogen citrate acidity regulator, Sequestrant, Stabilizer

371. 536 Potassium ferrocyanide anticaking agent

372. 366 Potassium fumarates Acidity regulator

373. 577 Potassium gluconate Sequestrant

374. 501 (ii) Potassium hydrogen carbonate acidity regulator, stabilizer

375. 351 (i) Potassium hydrogen malate Acidity regulator

376. 525 Potassium hydroxide Acidity regulator

377. 632 Potassium Inosate flavour enhancer

378. 917 Potassium iodate flour treatment agent

379. 317 Potassium isoascorbate Antioxidant

380. 326 Potassium lactate Antioxidant, synergist, acidity Regulator

381. 351 (ii) Potassium malate Acidity regulator

382. 351 Potassium malates Acidity regulator

383. 224 Potassium metabisulphite Preservative, antioxidant

384. 252 Potassium nitrate Preservative, colour fixative

385. 249 Potassium nitrite Preservative, colour fixative

386. 922 Potassium persulphate flour treatment agent

387. 340 Potassium phosphates acidity regulator, Sequestrant, emulsifier, Texturizer, Stabilizer, water retention agent

388. 452 (ii) Potassium polyphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

389. 283 Potassium propionate Preservative

390. 560 Potassium silicate anticaking agent

391. 337 Potassium sodium tartrate Stabilizer, sequestrant

392. 202 Potassium sorbate Preservative

393. 515 Potassium sulphates Acidity regulator

394. 225 Potassium sulphite Preservative, antioxidant

395. 336 Potassium tartrates Stabilizer, sequestrant

396. 460 (ii) Powdered cellulose Emulsifier, anticaking agent, texturizer, dispersing agent

397. 407 a Processed Euchema seaweed Thickener, stabilizer

398. 944 Propane Propellant

399. 280 Propionic acid Preservative

400. 310 Propyl gallate Antioxidant

401. 216 Propyl p-hydroxybenzoate Preservative

402. 1520 Propylene glycol Humectant, wetting agent, dispersing agent

403. 405 Propylene glycol alginate Thickener, emulsifier

404. 477 Propylene glycol esters of fatty acids

Emulsifier

Page 302: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 711

Sl. No. INS Number Food Additive Name Technical functions

405. 1101 (i) Protease flour treatment agent, Stabilizer, tenderizer, flavour Enhancer

406. 1101 Proteases flour treatment agent, Stabilizer, tenderizer, flavour Enhancer

407. 999 Quillaia extracts foaming agent

408. 104 Quinoline yellow Colour

409. 128 Red 2G Colour

410. 161 f Rhodoxanthin Colour

411. 101 (i) Riboflavin Colour

412. 101 (ii) Riboflavin 5' -phosphate, sodium Colour

413. 101 Riboflavins Colour

414. 908 Rice bran wax glazing agent

415. 161 d Rubixanthin Colour

416. 954 Saccharin (and Na, K, Ca salts) Sweetener

417. 470 Salts of fatty acids (with base Al, Ca, Na, Mg, K and NH4)

Emulsifier, Stabilizer, anti caking agent

418. 166 Sandalwood Colour

419. 904 Shellac glazing agent

420. 551 Silicon dioxide, amorphous anticaking agent

421. 174 Silver Colour

422. 262 (i) Sodium acetate Preservative, acidity regulator, Sequestrant

423. 262 Sodium acetates Preservative, acidity regulator, Sequestrant

424. 356 Sodium adipates Acidity regulator

425. 401 Sodium alginate Thickener, Stabilizer, gelling Agent

426. 541 Sodium aluminium phosphate acidity regulator, emulsifier

427. 541 (i) Sodium aluminium phosphate- acidic acidity regulator, emulsifier

428. 541 (ii) Sodium aluminium phosphate-basic acidity regulator, emulsifier

429. 554 Sodium alumino-silicate anticaking agent

430. 301 Sodium ascorbate Antioxidant

431. 211 Sodium benzoate Preservative

432. 452 (iii) Sodium calcium polyphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

433. 500(i) Sodium carbonate acidity regulator, raising agent, anticaking agent

434. 500 Sodium carbonates acidity regulator, raising agent, anticaking agent

435. 466 Sodium carboxymethyl cellulose Thickener, Emulsifier, Stabilizer

436. 469 Sodium carboxymethyl, cellulose, enzymatically, hydrolysed

Thickener, stabilizer

437. 331 Sodium citrates acidity regulator, Sequestrant, emulsifier, stabilizer

Page 303: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

712 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

438. 266 Sodium dehydroacetate Preservative

439. 262 (ii) Sodium diacetate Preservative, acidity regulator, Sequestrant

440. 331 (i) Sodium dihydrogen citrate acidity regulator, Sequestrant, emulsifier, stabilizer

441. 215 Sodium ethyl p-hydroxybenzoate Preservative

442. 535 Sodium ferrocyanide anticaking agent

443. 237 Sodium formate Preservative

444. 365 Sodium fumarates Acidity regulator

445. 576 Sodium gluconate Sequestrant

446. 500 (ii) Sodium hydrogen carbonate acidity regulator, raising agent, anticaking agent

447. 350 (i) Sodium hydrogen malate acidity regulator, humectant

448. 222 Sodium hydrogen sulphite Preservative, antioxidant

449. 524 Sodium hydroxide Acidity regulator

450. 316 Sodium isoascorbate Antioxidant

451. 638 Sodium L-Aspartate flavour enhancer

452. 325 Sodium lactate antioxidant synergist, Humectant, bulking agent

453. 481 Sodium lactylates Emulsifier, stabilizer

454. 487 Sodium laurylsulphate Emulsifier

455. 350 (ii) Sodium malate acidity regulator, humectant

456. 350 Sodium malates acidity regulator, humectant

457. 223 Sodium metabisulphite Preservative, bleaching agent, Antioxidant

458. 550 (ii) Sodium metasilicate anticaking agent

459. 219 Sodium methyl p-hydroxybenzoate Preservative

460. 251 Sodium nitrate Preservative, colour fixative

461. 250 Sodium nitrite Preservative, colour fixative

462. 232 Sodium o-phenylphenol Preservative

463. 481 (ii) Sodium oleyl lactylate Emulsifier, stabilizer

464. 339 Sodium phosphates acidity regulator, Sequestrant, emulsifier, Texturizer, Stabilizer, water retention agent

465. 452 (i) Sodium polyphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

466. 281 Sodium propionate Preservative

467. 217 Sodium propyl p-hydroxybenzoate Preservative

468. 500 (iii) Sodium sesquicarbonate acidity regulator, raising agent, anticaking agent

469. 550 (i) Sodium silicate anticaking agent

470. 550 Sodium silicates anticaking agent

471. 201 Sodium sorbate Preservative

472. 485 Sodium stearoyl fumarate Emulsifier

Page 304: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 713

Sl. No. INS Number Food Additive Name Technical functions

473. 481 (i) Sodium stearoyl lactylate Emulsifier, stabilizer

474. 514 Sodium sulphates Acidity regulator

475. 221 Sodium sulphite Preservative, antioxidant

476. 335 Sodium tartrates Stabilizer, sequestrant

477. 539 Sodium thiosulphate Antioxidant, sequestrant

478. 200 Sorbic acid Preservative

479. 493 Sorbitan monolaurate Emulsifier

480. 494 Sorbitan mono-oleate Emulsifier

481. 495 Sorbitan monopalmitate Emulsifier

482. 491 Sorbitan monostearate Emulsifier

483. 496 Sorbitan trioleate Stabilizer, emulsifier

484. 492 Sorbitan tristearate Emulsifier

485. 420 Sorbitol and sorbitol syrup Sweetener, Humectant, sequestrant, Texturizer, Emulsifier

486. 909 Spermacetic wax glazing agent

487. 512 Stannous chloride Antioxidant, colour retention agent

488. 484 Stearyl citrate Emulsifier, sequestrant

489. 483 Stearyl tartrate flour treatment agent

490. 960 Stevioside Sweetener

491. 363 Succinic acid Acidity regulator

492. 472g Succinylated monoglycerides Emulsifier, Stabilizer, Sequestrant

493. 446 Succi stearin Emulsifier

494. 955 Sucralose Sweetener

495. 474 Sucroglycerides Emulsifier

496. 444 Sucrose acetate isobutyrate Emulsifier, stabilizer

497. 473 Sucrose esters of fatty acids Emulsifier

498. 220 Sulphur dioxide Preservative, antioxidant

499. 513 Sulphuric acid acidity regulator

500. 110 Sunset yellow FCF colour

501. 441 Superglycerinated hydrogenated rapeseed oil Emulsifier

502. 309 Synthetic delta-tocopherol Antioxidant

503. 308 Synthetic gamma-tocopherol Antioxidant

504. 553 (iii) Talc anticaking agent, dusting powder

505. 181 Tannins, food grade Colour, Emulsifier, Stabilizer, thickener

506. 417 Tara gum Thickener, stabilizer

507. 334 Tartaric acid (L(+)-) acidity regulator, Sequestrant, antioxidant synergist

508. 472 d Tartaric acid esters of mono and di-glycerides of fatty acids

Emulsifier, Stabilizer, sequestrant

509. 102 Tartrazine Colour

510. 319 Tertiary butylhydroquinone antioxidant

Page 305: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

714 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. INS Number Food Additive Name Technical functions

511. 450(v) Tetrapotassium diphosphate emulsifier, raising agent, stabilizer sequestrant, acidity regulator, water retention agent

512 450 (iii) Tetrasodium diphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Seque-strant, water retention agent

513. 957 Thaumatin Sweetener, flavour enhancer emulsifier

514. 479 Thermally oxidized soya bean oil with mono-and di-glycerides of fatty acids

Emulsifier

515. 233 Thiabendazole Preservative

516. 388 Thiodipropionic acid antioxidant

517. 171 Titanium dioxide Colour

518. 413 Tragacanth gum Thickener, Stabilizer, emulsifier

519. 1518 Triacetin Humectant

520. 341 (iii) Tricalcium orthophosphate acidity regulator, texturizer, flour treatment agent, raising agent, firming agent, anticaking agent, water retention agent

521. 1505 Triethyl citrate foam stabilizer

522. 343 (iii) Trimagnesium orthophosphate acidity regulator, anticaking Agent

523. 451 Tri phosphates Sequestrant, acidity regulator, Texturizer

524. 332 (ii) Tripotassium citrate acidity regulator, Sequestrant, Stabilizer

525. 340 (iii) Tripotassium orthophosphate acidity regulator, texturizer, sequestrant stabilizer, Emulsifier, water retention Agent

526. 331 (ii) Trisodium citrate acidity regulator, Sequestrant, emulsifier, Stabilizer

527. 450 (ii) Trisodium diphosphate Emulsifier, Stabilizer, acidity regulator, raising agent, Sequestrant, water retention Agent

528. 339 (iii) Trisodium orthophosphate acidity regulator, Sequestrant, emulsifier, Texturizer, Stabilizer, water retention agent

529. 100 (ii) Turmeric Colour

530. 153 Vegetable carbon Colour

531. 161 e Violoxanthin Colour

532. 910 Wax esters glazing agent

533. 415 Xanthan gum Thickener, stabilizer

534. 967 Xylitol Sweetener, Humectant, stabilizer, Emulsifier, thickener

535. 107 Yellow 2G Colour

536. 557 Zinc silicate anticaking agent

Supplementary List-Modified Starches

537. 1422 Acetylated di-starch adipate Stabilizer, thickener, binder

538. 1423 Acetylated distarch glycerol Stabilizer, thickener

Page 306: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 715

Sl. No. INS Number Food Additive Name Technical functions

539. 1414 Acetylated distarch phosphate Emulsifier, thickener

540. 1401 Acid-treated starch Stabilizer, thickener, binder

541. 1402 Alkaline treated starch Stabilizer, thickener, binder

542. 1403 Bleached starch Stabilizer, thickener, binder

543. 1400 Dextrins roasted starch white and yellow Stabilizer, thickener, binder

544. 1411 Di-starch glycerol Stabilizer, thickener, binder

545. 1412 Di-starch phosphate esterified with sodium trimetaphosphate; esterified with phosphorus oxychloride

Stabilizer, thickener, binder

546. 1443 Hydroxypropyl di-starch glycerol Stabilizer, thickener

547. 1442 Hydroxypropyl di-starch phosphate Stabilizer, thickener

548. 1440 Hydroxypropyl starch Emulsifier, thickener, binder

549. 1410 Monostarch phosphate Stabilizer, thickener, binder

550. 1404 Oxidized starch Emulsifier, thickener, binder

551. 1413 Phosphated di-starch phosphate Stabilizer, thickener, binder

552. 1420 Starch acetate esterified with acetic anhydride Stabilizer, thickener

553. 1421 Starch acetate esterified with vinyl acetate Stabilizer, thickener

554. 1450 Starch sodium octenyl succinate Stabilizer, thickener, binder,

555. 1405 Starches, enzyme-treated thickener

Page 307: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

716 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

2. Use of Food Additives in Food Products: Food products may contain additives as specified in the Regulations and in the following tables

Table 1

List of food additives for use in bread and biscuits

Sl. No. Name of additive Bread Biscuits

A. Acidity regulators

1. Sodium fumarate GMP GMP

2. Potassium malate GMP GMP

3. Sodium hydroxide GMP GMP

4. Acetic acid or Lactic acid 2500 ppm max GMP

5. Citric acid - GMP

6. Malic acid - GMP

7. Tartaric acid - GMP

B. Emulsifying and stabilizing agents singly or in combination

- Emulsifying and stabilizing agents listed in regulation 6.1.6 suitable for this product may be used.

1. Sucroglycerides - 1000 ppm max

2. Hydroxy Propyl methyl cellulose GMP GMP

3. Sucrose esters of fatty acids GMP GMP

4. Di- Acetyl tartaric acid esters of mono and di- glycerides

GMP 10000 ppm max

5. Guar gum 5000 ppm max -

6. Sorbitol GMP -

7. Lecithin GMP -

8. Glycerine GMP -

9. Glycerol monostearate GMP -

10. Sodium steroyl 2 lactylate of Calcium steroyl 2 lactylate(Singly or in combination)

5000 ppm max

11. Polyglycerol esters of fatty acids and polyglycerol esters of interesterified recinoleic acid

2000 ppm max -

C. Improver

1. Fungal alpha amylase 100 ppm max (on flour mass basis)

-

2. Bacterial amylase GMP GMP

3. Amylases and other enzymes - GMP

4. Ammonium persulphate 2500 ppm max (on flour mass basis)

-

5. Calcium phosphate 2500 ppm max (on flour mass basis)

-

6. Calcium carbonate 5000 ppm max (on flour mass basis)

-

7. Potassium bromate and/or Potassium iodate 50 ppm max (On flour mass basis)

-

Page 308: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 717

Sl. No. Name of additive Bread Biscuits

D. Flour treatment agent

1. Ammonium chloride 500 ppm max (on flour mass basis)

-

2. L- cystein mono hydrochloride 90 ppm max (on flour mass basis)

-

3. Ammonium phosphate 2500 ppm max (on flour mass basis)

-

4. Benzoyl peroxide 40 ppm max 40 ppm max

E. Antioxidant - As per regulation 6.1.5

1. Ascorbic acid GMP GMP

F. Preservatives/ Mould inhibitors singly or in combination

1. Calcium or sodium propionate 5000 ppm max -

2. Sorbic acid or its Sodium, Potassium or Calcium salts (calculated as sorbic acid)

1000 ppm max -

3. Acid calcium phosphate 10000 ppm max -

4. Sodium diacetate 4000 ppm max -

5. Acid sodium pyrophosphate 5000 ppm max -

G. Colours (can be used singly or in combination within the specified limits)

a. Natural

1. Chlorophyll - GMP

2. Caramel -

3. Curcumin or turmeric -

4. Beta carotene -

5. Beta apo-8 carotenal -

6. Methyl ester of Beta apo-8 carotenic acid -

7. Ethyl ester of Beta apo-8 carotenic acid -

8. Canthaxanthin -

9. Riboflavin, Lactoflavin -

10. Annato -

11. Saffron -

b. Synthetic

1. Ponceau 4R - 100 ppm max (singly or in combination)

2. Carmoisine -

3. Erythrosine -

4. Tartrazine -

5. Sunset Yellow FCF -

6. Indigo carmine -

7. Brilliant blue FCF -

8. Fast green FCF -

Page 309: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

718 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl. No. Name of additive Bread Biscuits

H. Artificial sweeteners (Singly)

1. Aspartame 2200 ppm max 2200 ppm max

2. Acesulphame K 1000 ppm max 1000 ppm max

3. Sucralose 750 ppm max 750 ppm max

I. Leavening agents

1. Baking powder GMP GMP

2. Ammonium bi-carbonate GMP GMP

3. Ammonium carbonate 5000 ppm max 5000 ppm max

J. Flavours

1 Natural flavours and natural flavouring substances/ Nature identical flavouring substances/ Artificial flavouring substances

- GMP

K. Flavour improver/ enhancer - GMP

L. Nutrient

1. Calcium and ferrous salts - GMP

2. Potassium iodate - GMP

M. Dough conditioners

1. Sodium bisulphite - GMP

2. Sodium metabisulphite - GMP

N. Yeast GMP GMP

O. Jellifying agents - GMP

Page 310: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 719T

able

2

Lis

t of

Foo

d A

ddit

ives

for

use

in F

oods

Sl.

No.

A

dditi

ves

Snac

ks/ S

avou

ries

(Frie

d Pr

oduc

ts):-

Chi

wda

, B

hujia

, Dal

mot

h,

Kad

ubal

e, K

hara

boon

di,

Spic

ed &

Frie

d da

ls,

bana

na c

hips

and

sim

ilar

frie

d pr

oduc

ts s

old

by

any

nam

e

Swee

ts (C

arbo

hydr

ates

ba

sed

and

Milk

pro

duct

ba

sed)

:- H

alw

a, M

ysor

e Pa

k, B

oond

i Lad

oo, J

aleb

i, K

hoya

Bur

fi, P

eda,

Gul

ab

Jam

un, R

asog

olla

and

Si

mila

r milk

pro

duct

bas

ed

swee

ts s

old

by a

ny n

ame

Ista

nt m

ixes

suc

h as

id

li m

ix, d

osa

mix

, up

ma

mix

, pon

gal

mix

, pu

liyog

are

mix

, gul

ab ja

mun

m

ix, j

aleb

i mix

, va

da m

ix, e

tc

Ric

e an

d Pu

lses

ba

sed

Papa

ds

Rea

dy-to

-Se

rve

Bev

erag

es

Tea/

Cof

fee

base

d

Che

win

g gu

m/

Bub

ble

gum

Suga

r bas

ed/

Suga

r fre

e co

nfec

tione

ryC

hoco

late

sSy

nthe

tic

syru

p fo

r di

spen

sers

Lo-

zeng

es

1 2

3 4

5 6

7 8

9 10

11

12

A

Ant

ioxi

dant

s

1 To

coph

erol

G

MP

GM

P -

- -

- -

- -

-

2 Le

cith

in

GM

P G

MP

- -

- -

- -

- -

3 B

utyl

ated

hyd

roxy

ani

sole

(BH

A)

200

ppm

max

20

0 pp

m m

ax

- -

- 25

0 pp

m

max

-

- -

-

4 Te

rtiar

y bu

tyl h

ydro

qui

none

(T

BH

Q)

200

ppm

max

20

0 pp

m m

ax

- -

- -

- -

- -

B

Em

ulsi

fier/

Sta

bilis

er

1 M

ethy

l cel

lulo

se

0.5%

max

0.

5% m

ax

- -

- -

- -

- -

2 C

arbo

xym

ethy

l cel

lulo

se

0.5%

max

0.

5% m

ax

- -

- -

- -

- -

3 G

ella

n gu

m

- -

- -

- -

2% m

ax (i

n su

gar

boile

d co

nfec

tione

ry o

nly)

- -

-

C

Pres

erva

tives

1 So

rbic

aci

d an

d its

sod

ium

, po

tass

ium

and

cal

cium

sal

ts

(cal

cula

ted)

as

sorb

ic a

cid

- 10

00 p

pm m

ax

0.5%

max

0.

1%

max

30

0 pp

m

max

-

- -

- -

2 B

enzo

ic a

cid

- 30

0 pp

m m

ax

- -

- -

- -

- -

D

Ant

icak

ing

agen

ts

1 C

arbo

nate

s of

cal

cium

and

M

agne

sium

-

- N

ot m

ore

than

2.

0% m

ax, s

ingl

y -

- -

- -

- -

Page 311: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

720 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

2 Ph

osph

ates

of c

alci

um a

nd

Mag

nesi

um

- -

- -

- -

- -

-

3 Si

licat

es o

f Cal

cium

, Mag

nesi

um, o

r So

dium

or S

ilico

n di

xoid

e -

- -

- -

- -

- -

4 M

yris

tate

s, p

alm

itate

s or

ste

arat

es o

f al

umin

ium

, am

mon

ium

, cal

cium

, po

tass

ium

or s

odiu

m

- -

or in

com

bina

tion

- -

- -

- -

-

E

Ari

ficia

l sw

eete

ners

(sin

gly)

1 A

sper

tam

e -

200

ppm

max

-

- -

1000

0 pp

m

max

1000

0 pp

m

max

2000

pp

m

max

3000

pp

m m

ax

-

2 A

cesu

lpha

me

K

- 50

0 pp

m m

ax

- -

- 50

00

ppm

m

ax

3500

ppm

m

ax

500

ppm

m

ax

1500

pp

m m

ax

-

3 Sa

ccha

rin S

odiu

m

- 50

0 pp

m m

ax

- -

- 30

00

ppm

m

ax

3000

ppm

m

ax

500

ppm

m

ax

450

ppm

m

ax

-

4 Su

cral

ose

- 75

0 pp

m m

ax

- -

-

- -

- 15

00

ppm

m

ax

F Po

lyol

s (s

ingl

y or

in c

ombi

natio

n)

1 So

rbito

l -

GM

P -

- -

GM

P G

MP

GM

P -

GM

P

2 M

anito

l -

GM

P -

- -

GM

P G

MP

GM

P -

GM

P

3 X

ylito

l -

GM

P -

- -

GM

P G

MP

GM

P -

GM

P

4 Is

omal

t -

- -

- -

GM

P G

MP

GM

P -

GM

P

5 La

ctito

l -

- -

- -

GM

P G

MP

GM

P -

GM

P

6 M

altit

ol

- -

- -

- G

MP

GM

P G

MP

- G

MP

G

Gla

zing

age

nts

1 Sh

ella

c -

- -

- -

- -

GM

P -

-

2 B

eesw

ax (w

hite

and

yel

low

) -

- -

- -

- -

GM

P -

-

3 C

ande

lilla

wax

-

- -

- -

- -

GM

P -

-

4 G

um a

rabi

c -

- -

- -

- -

GM

P -

-

Page 312: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7211

2 3

4 5

6 7

8 9

10

11

12

5 Pe

ctin

-

- -

- -

- -

GM

P -

-

H

Bul

king

age

nts

1 Po

lyde

xtro

se A

and

N

- -

- -

- -

- G

MP

- -

I M

isce

llane

ous

1 So

dium

bic

arbo

nate

-

- G

MP

- -

- -

- -

-

2 So

dium

ace

tate

-

- G

MP

- -

- -

- -

-

3 Ta

rtaric

aci

d -

- G

MP

- -

- -

- -

-

4 C

itric

aci

d -

- G

MP

- -

- -

- -

-

5 M

alic

aci

d -

- G

MP

- -

- -

- -

-

Page 313: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

722 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

3

Foo

d A

ddit

ives

in F

oods

not

spe

cifi

ed

S. N

o.

Nam

e of

the

prod

uct

Col

ours

Pr

eser

vativ

es

Emul

sifie

rs/ S

tabi

liser

s Fl

avou

r en

hanc

ers

Ant

icak

ing

agen

ts

Aci

d re

gula

tors

Impr

over

/ Le

aven

ing

agen

ts

Ant

ioxi

dant

s

1 D

eser

t jel

ly

Cara

geen

an G

MP

- -

- -

2 D

airy

bas

ed d

rinks

, fla

vour

ed an

d/ o

r fe

rmen

ted

(e.g

ch

ocol

ate,

milk

, coc

oa,

eggn

og) U

HT

steril

ized

m

ilk sh

elf l

ife m

ore

than

thre

e mon

ths

- -

Cara

geen

an- S

ingl

y- G

MP

Pect

in- S

ingl

y- G

MP

Mon

o an

d di

glyc

erid

es o

f fat

ty ac

ids

– Si

ngly

– G

MP

leci

thin

Sing

ly G

MP

sodi

um al

gina

te

and

calc

ium

algi

nate

– si

ngly

G

MP,

Xan

tham

Gum

, sin

gly-

G

MP,

Mic

rocr

ysta

lline

ce

llulo

se si

ngly

GM

P, G

uar

Gum

- Sin

gly

- GM

P

- -

- -

-

3 Po

wde

red

Soft

Drin

k co

ncen

tera

te m

ix/ f

ruit

beve

rage

drin

k

Tita

nium

Dio

xide

100

ppm

m

axim

um,

Ponc

eau

4R

carm

oisin

e/ E

ryth

rosin

e/

Tartr

azin

e/ S

unse

t Yel

low

FC

F/ In

digo

Car

min

e/

Brill

iant

Blu

e FCF

/ fas

t gr

een

FCF

100

ppm

m

axim

um

- -

- So

dium

A

lum

iniu

m

Silic

ate –

0.

5%

max

imum

- -

-

4 So

ups,

Bulli

ons a

nd

Taste

Mak

ers

- -

- D

i- So

dium

5

Gua

nyla

te

(Di–

Sodi

um 5

- In

osin

ate)

- G

MP

- -

- -

5 Cu

stard

Pow

der,

Jelly

Cr

ysta

l, ic

ecan

dy,

Thre

ad, C

andi

es,

Waf

ers

Ponc

eau

4R/

carm

oisin

e/Er

ythr

osin

e/

Tartr

azin

e/Su

nset

Yel

low

FC

F/ In

digo

Car

min

e/

Brill

iant

Blu

e FCF

/ fas

t gr

een

FCF-

100

ppm

m

axim

um

- -

- -

- -

-

Page 314: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 723S.

No.

N

ame

of th

e pr

oduc

t C

olou

rs

Pres

erva

tives

Em

ulsi

fiers

/ Sta

bilis

ers

Flav

our

enha

ncer

s A

ntic

akin

g ag

ents

A

cid

regu

lato

rsIm

prov

er/

Leav

enin

g ag

ents

A

ntio

xida

nts

6 Fl

avou

r Em

ulsio

n,

Flav

our P

aste

( fo

r ca

rbon

ated

and

non

carb

onat

ed w

ater

onl

y)

Ponc

eau

4R/c

arm

oisin

e/

Eryt

hros

ine/

Tar

trazi

ne/

Suns

et Y

ello

w F

CF/ I

ndig

o Ca

rmin

e/ B

rillia

nt B

lue

FCF/

fast

gree

n FC

F 10

0 pp

m m

axim

um as

per

in

struc

tions

on

the l

abel

Benz

oic A

cid

incl

udin

g sa

lt th

ereo

f GM

P Ed

ible

Gum

s ( A

rabi

c and

G

um g

hatti

), gl

ycer

ols e

sters

of

woo

d re

sins (

este

r gum

) -

GM

P

- -

- -

TBH

Q (t

ertia

ry

buty

l hyd

ro

quin

ine a

nd

BHA

(b

utyl

ated

hy

drox

yl

aniso

le) –

max

0.

01%

7 Sa

usag

es an

d Sa

usag

e m

eat c

onta

inin

g ra

w

mea

t, ce

real

s and

co

ndim

ents

- Su

lphu

r dix

oide

- 450

pp

m m

ax

- -

- -

- -

8 Co

rn fl

our a

nd su

ch

like s

tarc

hes

- Su

lphu

r dix

oide

- 100

pp

m m

ax

- -

- -

- -

9 Co

rn sy

rup

- Su

lphu

r dix

oide

- 450

pp

m m

ax

- -

- -

- -

10

Cann

ed ra

sgol

la (t

he

cans

shal

l be i

nter

nally

la

cque

red

with

sulp

hur

diox

ide r

esist

ant

lacq

uer)

- N

isin-

5 pp

m m

axim

um

- -

- -

- -

11

Gel

atin

-

Sulp

hur d

ixoi

de- 1

000

ppm

max

-

- -

- -

-

12

Beer

-

Sul

phur

dix

oide

- 70

ppm

m

ax

- -

- -

- -

13

Cide

r -

Sulp

hur d

ixoi

de- 2

00

ppm

max

-

- -

- -

-

14

Alc

ohol

ic w

ines

-

Sulp

hur d

ixoi

de- 4

50

ppm

max

-

- -

- -

-

15

Non

Alc

ohol

ic w

ines

-

Sulp

hur d

ixoi

de- 3

50

ppm

max

-

- -

- -

-

16

Read

y-to

-ser

ve

beve

rage

s -

Sulp

hur d

ixoi

de- 7

0 pp

m

max

or B

enzo

ic ac

id- 1

20

ppm

max

- -

- -

- -

Page 315: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

724 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]S.

No.

N

ame

of th

e pr

oduc

t C

olou

rs

Pres

erva

tives

Em

ulsi

fiers

/ Sta

bilis

ers

Flav

our

enha

ncer

s A

ntic

akin

g ag

ents

A

cid

regu

lato

rsIm

prov

er/

Leav

enin

g ag

ents

A

ntio

xida

nts

17

Brew

ed g

inge

r bee

r -

Benz

oic a

cid-

120

ppm

m

ax

- -

- -

- -

18

Coffe

e ext

ract

-

Benz

oic A

cid-

450

ppm

m

axim

um

- -

- -

- -

19

Dan

ish ti

nned

cavi

ar

- Be

nzoi

c Aci

d- 5

0 pp

m

max

imum

-

- -

- -

-

20

Drie

d gi

nger

-

Sulp

hur d

ioxi

de- 2

000

ppm

max

imum

-

- -

- -

-

21

Flou

r con

fect

ione

ry

- So

rbic

Aci

d in

clud

ing

Sodi

um, P

otas

ium

and

Calc

ium

Sal

t Cal

cula

ted

as S

orbi

c Aci

d)- 1

500

ppm

max

imum

- -

- -

- -

22

Smok

ed fi

sh (i

n w

rapp

ers)

-

Sor

bic A

cid-

onl

y w

rapp

er m

ay b

e im

preg

nate

d w

ith S

orbi

c A

cid

- -

- -

- -

23

Dry

mix

of r

asog

olla

s -

Sulp

hur d

ioxi

de- 1

00

ppm

max

imum

-

- -

- -

-

24

Pres

erve

d ch

apat

is -

Sorb

ic A

cid-

150

0 pp

m

max

imum

-

- -

- -

-

25

fat s

prea

d -

Sorb

ic ac

id an

d its

so

dium

pot

assiu

m an

d ca

lciu

m sa

lts (c

alcu

late

d as

sorb

ic ac

id)-1

000

ppm

m

axim

um o

r Ben

zoic

A

cid

and

its so

dium

and

pota

ssiu

m sa

lts

(Cal

cula

ted

as b

enzo

ic

acid

) or b

oth-

1000

ppm

m

axim

um

- -

- -

- -

26

Prun

es

- Po

tass

ium

Sor

bate

(C

alcu

late

d as

Sor

bic

Aci

d)- 1

000

ppm

m

axim

um

- -

- -

- -

Page 316: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 725S.

No.

N

ame

of th

e pr

oduc

t C

olou

rs

Pres

erva

tives

Em

ulsi

fiers

/ Sta

bilis

ers

Flav

our

enha

ncer

s A

ntic

akin

g ag

ents

A

cid

regu

lato

rsIm

prov

er/

Leav

enin

g ag

ents

A

ntio

xida

nts

27

Bake

s foo

d co

nfec

tions

an

d ba

kes f

oods

-

Am

mon

ia C

arbo

nate

-500

0 pp

m m

axim

um A

mm

oniu

m

Bi-c

arbo

nate

- GM

P,

Baki

ng p

owde

r-GM

P

- -

- -

- -

28

Flou

r for

bak

ed fo

ods

- So

dium

Dia

ceta

te-

2500

ppm

max

imum

or

Met

hyl p

ropy

l hyd

roxy

Be

nzoa

te- 5

00 p

pm

max

imum

- -

- -

- -

29

Frui

t, fru

it pu

lp o

r jui

ce

(not

drie

d) fo

r co

nver

sion

into

jam

or

crys

talli

sed

glac

e or

cure

d fru

it or

oth

er

prod

ucts

-

-

- -

- -

(a)

Cher

ries

- Su

lphu

r dio

xide

- 200

0 pp

m m

axim

um

- -

- -

- -

(b)

Stra

wsb

errie

s and

Ra

spbe

rries

-

Sulp

hur d

ioxi

de- 2

000

ppm

max

imum

-

- -

- -

-

(c)

Oth

er fr

uits

- Su

lphu

r dio

xide

- 100

0 pp

m m

axim

um

- -

- -

- -

(d)

Deh

ydra

ted

Veg

etab

les

- Su

lphu

r dio

xide

- 200

0 pp

m m

axim

um

- -

- -

- -

30

Pane

er

- N

isin-

12.5

ppm

m

axim

um

- -

- -

- -

31

Cake

s and

Pas

tries

-

Sorb

ic A

cid

incl

udin

g So

dium

, Pot

assiu

m an

d Ca

lciu

m S

alt (

Calc

ulat

ed

as S

orbi

c Aci

d)- 1

500

ppm

max

imum

Sucr

ogly

cerid

es (o

nly

In

cake

s), H

ydro

xypr

opyl

M

ethy

l Cel

lulo

se, S

ucro

se

este

rs o

f fat

ty ac

ids-

GM

P

- -

Sodi

um

fum

arat

e, Po

tass

ium

M

alat

e, So

dium

hy

drox

ide-

G

MP

Bact

eria

l Am

ylas

e Ba

king

Pow

der,

Am

mon

ium

bi

carb

onat

e GM

P,

Am

mon

ium

Ca

rbon

ate-

500

pp

m m

axim

um

-

32

Prep

acke

d Co

conu

t W

ater

-

Nisi

n-50

00 IU

max

imum

-

- -

- -

-

33

Cann

ed R

asog

ula

- N

isin-

5.0

ppm

max

imum

-

- -

- -

-

Page 317: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

726 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

4

Lis

t of

foo

d ad

diti

ves

for

use

in e

dibl

e oi

ls a

nd f

ats

N

ame

of fo

od a

dditi

ve

Tallo

w

Lard

Ed

ible

veg

etab

le o

ils

and

fats

Ta

ble

mar

gari

ne/ B

aker

y an

d in

dust

rial

Mar

gari

ne/ F

at s

prea

d

A

Ant

ioxi

dant

(Sin

gly

or in

com

bina

tion)

1 Le

cith

in

GM

P

GM

P

GM

P

GM

P

2 A

scor

bic

acid

G

MP

G

MP

G

MP

G

MP

3 Pr

opyl

gal

late

, eth

yl g

alla

te, O

ctyl

gal

late

, Dod

ecyl

gal

late

or a

m

ixtu

re th

ereo

f 10

0 pp

m m

ax

10

0 pp

m m

ax

10

0 pp

m m

ax

20

0 pp

m m

ax

4 B

utyl

ated

Hyd

roxy

Ani

sole

(BH

A)

200

ppm

max

20

0 pp

m m

ax

200

ppm

max

20

0 pp

m m

ax

5 A

ny c

ombi

natio

n of

pro

pl g

alla

te, B

HA

with

in li

mits

of g

alla

te a

nd

BH

A

200

ppm

max

20

0 pp

m m

ax

200

ppm

max

20

0 pp

m m

ax

6 N

atur

al a

nd s

ynth

etic

toco

pher

ols

GM

P

GM

P

GM

P

GM

P

7 A

scor

byl p

alm

itate

/ ste

arat

e si

ngly

or i

n co

mbi

natio

n 50

0 pp

m m

ax

500

ppm

max

50

0 pp

m m

ax

500

ppm

max

8 C

itric

aci

d, T

arta

ric a

cid,

Gal

lic a

cid

GM

P

G

MP

GM

P

G

MP

9 R

esin

gui

nace

10

0 pp

m m

ax

10

0 pp

m m

ax

10

0 pp

m m

ax

50

0 pp

m m

ax

10

TBH

Q

200

ppm

max

20

0 pp

m m

ax

200

ppm

max

20

0 pp

m m

ax

B.

Ant

ioxi

dant

Syn

ergi

st

1 So

dium

citr

ate

GM

P

GM

P

GM

P

GM

P

2 Is

opro

pyl c

itrat

e m

ixtu

re

3 Ph

osph

oric

aci

d

4 M

onog

lyce

ride

citra

te

100

ppm

max

, Si

ngly

or i

n co

mbi

natio

n

100

ppm

max

, Si

ngly

or i

n co

mbi

natio

n

100

ppm

max

, Si

ngly

or i

n co

mbi

natio

n

100

ppm

max

, Sin

gly

or in

co

mbi

natio

n

C.

Ant

ifoam

ing

agen

ts

1 D

imet

hyl p

olys

iloxa

ne s

ingl

y or

in c

ombi

natio

n w

ith s

ilico

n di

oxid

e 10

ppm

max

10

ppm

max

10

ppm

max

-

D.

Em

ulsi

fyin

g ag

ents

1 M

ono

and

di g

lyce

rides

of f

atty

aci

ds

- -

- G

MP

2 M

ono

and

di g

lyce

rides

of f

atty

aci

ds e

ster

ified

with

ace

tic, a

cety

l ta

rtric

, citr

ic, l

actic

, tar

taric

aci

ds a

nd th

eir s

odiu

m a

nd c

alci

um s

alts

-

- -

10g/

kg m

ax

3 Le

cith

in

- -

- G

MP

4 Po

lygl

ycer

ol e

ster

s of

fatty

aci

ds

- -

- 5g

/kg

max

5 1,

2- P

ropy

lene

gly

col e

ster

s of

fatty

aci

ds

- -

- 20

g/kg

max

Page 318: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7276

Sorb

itan

mon

opal

mita

te/ S

orbi

tan

mon

oste

arat

e/ T

riste

arat

e -

- -

10g/

kg m

ax

7 Su

cros

e es

ters

of f

atty

aci

ds

- -

- 10

g/kg

max

E.

Pres

erva

tives

(Sin

gly

or in

com

bina

tion)

1

Sorb

ic a

cid

- -

- 2

Sodi

um/ P

otas

sium

/ Cal

cium

sor

bate

exp

ress

ed a

s So

rbic

aci

d -

- -

3 B

enzo

ic a

cid

- -

- 4

Sodi

um/ P

otas

sium

/ ben

zoat

e ex

pres

sed

as B

enzo

ic a

cid

- -

-

1000

mg/

kg m

ax: T

able

m

arag

rine/

Fat

spr

ead

F.

Nat

ural

col

ours

1 B

eta

caro

tene

-

- -

25 m

g/kg

max

: Tab

le

mar

agrin

e/ F

at s

prea

d

2 A

nnat

to e

xtra

cts

(as

bixi

n/ n

orbi

xin)

-

- -

20 m

g/kg

max

: Tab

le

mar

agrin

e/ F

at s

prea

d

3 C

urcu

min

or t

urm

eric

(As

curc

umin

) -

- -

5 m

g/kg

max

: Tab

le m

arag

rine/

Fa

t spr

ead

4 B

eta

- apo

- 8'

- ca

rote

nal

- -

- 25

mg/

kg m

ax: T

able

m

arag

rine/

Fat

spr

ead

5 m

ethy

l and

eth

yl e

ster

s of

bet

a - a

po -

8' -

caro

teno

ic a

cid

- -

- 25

mg/

kg m

ax: T

able

m

arag

rine/

Fat

spr

ead

G

. A

cidi

ty r

egul

ator

s

1 C

itric

aci

d

- -

- G

MP:

Tab

le m

arag

rine/

Fat

sp

read

2 La

ctic

aci

d -

- -

GM

P: T

able

mar

agrin

e/ F

at

spre

ad

3 So

dium

and

pot

assi

um s

alt o

f citr

ic a

nd la

ctic

aci

d -

- -

GM

P: T

able

mar

agrin

e/ F

at

spre

ad

4 C

alci

um d

isod

ium

eth

ylen

e di

amin

e te

tra a

ceta

te

- -

- 50

mg/

kg m

ax: T

able

m

arag

rine/

Fat

spr

ead

H

. Fl

avou

rs

1 N

atur

al fl

avou

rs a

nd n

atur

al fl

avou

ring

subs

tanc

es/ N

atur

e id

entic

al

flavo

urin

g su

bsta

nces

/ Arti

ficia

l fla

vour

ing

subs

tanc

es

- -

- G

MP:

Tab

le m

arag

rine/

Fat

sp

read

2 D

iace

tyl

- -

- 4

mg/

kg m

ax: T

able

mar

agrin

e/

Fat s

prea

d

Page 319: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

728 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4] T

able

5

Lis

t of

Foo

d A

ddit

ives

for

use

in F

ish

and

Fis

h P

rodu

cts

N

ame

of th

e A

dditi

ve

Froz

en s

hrim

ps

Froz

en L

obst

ers

Salte

d Fi

sh

Froz

en

finfis

h C

anne

d fin

fish

Can

ned

Shrim

psC

anne

d Sa

rdin

es

Can

ned

Tuna

an

d B

onito

C

anne

d C

rab

mea

t Fr

ozen

Fis

h Fi

llets

A

Ant

ioxi

dant

s

1 A

scor

bic

Aci

d G

MP

- -

- -

- -

- -

-

2 So

dium

and

Pot

assi

um

Ass

ocia

te s

ingl

y or

in

com

bina

tion

expr

esse

d as

A

scor

bic

acid

- 1g

m/k

g -

1 gm

/kg

max

imum

- -

- -

- 1

gm /

kg

max

imum

B

Aci

dify

ing

Age

nts

1 A

cetic

Aci

d -

- -

- G

MP

- G

MP

GM

P -

-

2 C

itric

aci

d G

MP

- -

- G

MP

GM

P G

MP

GM

P G

MP

1 gm

/kg

max

imum

in

min

ced

fish

flesh

on

ly

3 La

ctic

Aci

d -

- -

- G

MP

- G

MP

GM

P -

-

C

Moi

stur

e R

eten

tion

Age

nts

sing

ly o

r in

com

bina

tion

incl

udin

g na

tura

l pho

spha

te e

xpre

ssed

as

P 2O

5

1 So

dium

pol

ypho

spha

te

expr

esse

d as

P2O

5 -

- -

- -

2 Po

tass

ium

Pol

ypho

spha

te

expr

esse

d as

P2O

5 -

- -

- -

3 C

alci

um p

olyp

hosp

hate

ex

pres

sed

as P

2O5

100g

ms/

kg

max

imum

10

0gm

s/kg

m

axim

um

- -

- -

-

10 g

ms/

kg

max

imum

ex

pres

sed

as

P 2O

5

(incl

udin

g na

tura

l ph

osph

ate)

10 g

ms/

kg

max

imum

ex

pres

sed

as

P 2O

5

(incl

udin

g na

tura

l ph

osph

ate)

10 g

ms/

kg

max

imum

ex

pres

sed

as P

2O5

(incl

udin

g na

tura

l ph

osph

ate

)

4 O

rthop

hosp

horic

aci

d -

- -

- -

850

mg/

kg

max

imum

-

- -

-

D

Pres

erva

tives

1 Po

tass

ium

bis

ulph

ate

expr

esse

d as

Sul

phur

di

oxid

e

- -

- -

- -

- -

2.

Pota

ssiu

m S

ulph

ite

expr

esse

d as

sul

phur

di

oxid

e

100m

g/kg

m

axim

um ra

w

edib

le 3

0mg/

kg

max

imum

coo

ked

prod

uct.

Sing

ly

or in

com

bina

tion

100m

g/kg

m

axim

um

raw

edi

ble

30m

g/kg

m

axim

um

cook

ed

- -

- -

- -

- -

Page 320: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 729

Nam

e of

the

Add

itive

Fr

ozen

shr

imps

Fr

ozen

Lob

ster

sSa

lted

Fish

Fr

ozen

fin

fish

Can

ned

finfis

h C

anne

d Sh

rimps

Can

ned

Sard

ines

C

anne

d Tu

na

and

Bon

ito

Can

ned

Cra

b m

eat

Froz

en F

ish

Fille

ts

3.

Sodi

um m

etab

isul

phat

e ex

pres

sed

as s

ulph

ur

sulp

hur d

ioxi

de

- -

- -

- -

- -

4.

Sodi

um s

ulph

ite e

xpre

ssed

as

sor

bic

acid

expr

esse

d as

SO

2 pr

oduc

t. Si

ngly

or i

n co

mbi

natio

n co

oked

pr

oduc

t -

- -

- -

- -

-

5.

Sodi

um s

orba

te e

xpre

ssed

as

sor

bic

acid

-

-

6.

Cal

cium

sor

bate

exp

ress

ed

as s

orbi

c ac

id

- -

7.

Pota

ssiu

m s

orba

te

expr

esse

d as

sor

bic

acid

-

- -

- -

- -

- -

8.

Sorb

ic A

cid

- -

200

mg/

kg

max

imum

si

ngly

or i

n co

mbi

natio

n ex

pres

sed

as

sorb

ic a

cid

- -

- -

- -

-

E C

olou

rs

1 Po

ncea

u 4

R

30 m

g/kg

m

axim

um c

ooke

d m

ass

- -

- -

- -

- -

-

2.

Suns

et Y

ello

w

- -

- -

-

3.

Tarta

razi

ne

30 m

g/kg

m

axim

um

sing

ly o

r in

com

bina

tion

F.

Thi

cken

ing

Age

nts

1 Pe

ctin

-

- -

- 2.

5 gm

/kg

max

imum

-

- 2.

5 gm

/kg

max

imum

-

-

2 Tr

agac

anth

Gum

-

- -

- -

-

--

3.

Xan

than

Gum

-

- -

- -

-

--

4.

Sodi

um/ P

otas

sium

/ C

alci

um A

lgin

ate

- -

- -

- -

20 g

m/k

g m

axim

um

sing

ly o

r in

com

bina

tion

in p

acki

ng

med

ium

onl

y

20 g

m/k

g m

axim

um

sing

ly o

r in

com

bina

tion

in p

acki

ng

med

ium

onl

y

- 5

mg/

kg

max

imum

as

Sod

ium

A

lgin

ate

5.

Car

boxy

Met

hyl C

ellu

lose

-

- -

- 25

gm

/kg

max

imum

- -

- -

-

Page 321: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

730 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Nam

e of

the

Add

itive

Fr

ozen

shr

imps

Fr

ozen

Lob

ster

sSa

lted

Fish

Fr

ozen

fin

fish

Can

ned

finfis

h C

anne

d Sh

rimps

Can

ned

Sard

ines

C

anne

d Tu

na

and

Bon

ito

Can

ned

Cra

b m

eat

Froz

en F

ish

Fille

ts

G

Mod

ified

Sta

rche

s

1 A

cid

Trea

ted

Star

ch

- -

- -

- -

-

2 A

lkal

i Tre

ated

Sta

rch

- -

- -

- -

-

3 B

alan

ced

star

ched

-

- -

- -

- -

4 D

ista

rch

adip

ate

acet

ylat

ed

- -

- -

- -

-

5 D

ista

rch

glyc

erol

-

- -

- -

- -

6 D

ista

rch

glyc

erol

ac

etyl

ated

-

- -

- -

- -

7 D

ista

rch

glyc

erol

, hy

drox

ypro

pyl

- -

- -

- -

-

8 D

ista

rch

phos

phat

e -

- -

- -

- -

9 D

ista

rch

phos

phat

e,

acet

ylat

ed

- -

- -

- -

-

10

Dis

tarc

h ph

osph

ate

hydr

oxyp

ropy

l -

- -

- -

- -

11

Mon

osta

rch

phos

phat

e -

- -

- -

- -

12

Oxi

dize

d st

arch

-

- -

- -

- -

13

Star

ch a

ceta

te

- -

- -

- -

-

14

Star

ch, h

ydro

xypr

opyl

-

- -

-

60 g

m/k

g m

axim

um

sing

ly o

r in

com

bina

tion

in p

acki

ng

med

ium

on

ly

-

60 g

m/k

g m

axim

um

sing

ly o

r in

com

bina

tion

in p

acki

ng

med

ium

onl

y

60 g

m/k

g m

axim

um

sing

ly o

r in

com

bina

tion

in p

acki

ng

med

ium

onl

y

- -

H

Nat

ural

Fla

bour

s

1 N

atur

al fl

abou

rs a

nd

natu

ral f

lavo

urin

g su

bsta

nces

- -

- -

GM

P -

GM

P G

MP

- -

I Fl

avou

r E

nhan

cers

1 M

onos

odiu

m G

luta

mat

e -

- -

- -

- -

- 50

0 m

g/kg

m

axim

um

-

J Se

qest

erin

g A

gent

s

1.

Cal

cium

Dis

odiu

m E

DTA

-

- -

- -

250

mg/

kg

max

imum

-

- 25

0 m

g/kg

m

axim

um

-

Page 322: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 731T

able

6

Lis

t of

Foo

d A

ddit

ives

for

use

in T

herm

ally

Pro

cess

ed F

ruit

s

S.

No.

N

ame

of

Add

itive

s Pe

a-ch

es

Gra

pe

Frui

ts

Pine

appl

e Pl

ums

Ras

pbe

rrie

s Pe

as

Stra

w-

berr

ies

Ora

nge

Frui

t C

ockt

ail/

Trop

ical

Fr

uit

Coc

ktai

l

Apr

icot

Palm

ito

Man

-go

es

Gua

vaC

hicu

Pa

paya

Lich

i K

enu

Pom

egra

nate

C

usta

rd

App

le

Frui

ts

not

spec

i-fie

d

1 2

3 4

5 6

7 8

9 10

11

12

13

14

15

16

17

18

19

20

21

22

A

Aci

dify

ing

Age

nts

(Sin

gly

or in

C

ombi

natio

n)

1

Ace

tic A

cid

-

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

2

Citr

ic A

cid

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

PG

MP

GM

P G

MP

GM

P G

MP

GM

PG

MP

GM

PG

MP

GM

P G

MP

GM

P G

MP

3

Fum

aric

A

cid

- -

- -

- -

- -

- -

- -

- -

- -

- -

- -

4

Lact

ic A

cid

- -

- -

- G

MP

GM

P-

- -

GM

P -

GM

PG

MP

GM

PG

MP

GM

P G

MP

GM

P G

MP

B

Ant

-clo

udin

g A

gent

1

Met

hyl

Cel

lulo

se

10

pp

m

max

i-m

um

- -

-

- -

10 p

pm

max

i-m

um

- -

- -

- -

- -

- -

-

C

Ant

ifoam

ing

Age

nts

1

Dim

ethy

l Po

lisilo

xane

-

- 10

pp

m

max

i-m

um

- -

-

- -

- -

- -

- -

- -

- -

-

D

Ant

ioxi

dant

1 A

scor

bic

Aci

d 55

0 pp

m

max

i-m

um

550

ppm

m

axi-

mum

- -

- 55

0 pp

m

max

i-m

um

- 55

0 pp

m

max

i-m

um

550

ppm

m

axi-

mum

- 55

0 pp

m

max

i-m

um

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

550

ppm

m

axi-

mum

Page 323: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

732 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

E

Col

ours

(can

be

use

d si

ngly

or

in

com

bina

tion

with

in th

e sp

ecifi

ed

limits

(a)

Nat

ural

:

1 C

hlor

ophy

ll -

- -

- -

- -

2 C

aram

el

- -

- -

- -

-

3 C

urcu

min

or

turm

eric

-

- -

- -

- -

4 B

eta-

caro

tene

- -

- -

- -

-

5 B

eta

apo-

8 ca

rote

nal

- -

- -

- -

-

6 M

ethy

lest

er

of B

eta-

apo-

8 ca

rote

nic

acid

- -

- -

- -

-

7 Et

hyle

ster

of

Bet

a-ap

o-8

caro

teni

c ac

id

- -

- -

- -

-

8 C

anth

axan

thi

n -

- -

- -

- -

9 R

ibof

lavi

n,

Lact

ofla

vin

- -

- -

- -

-

10

Ann

atto

-

- -

- -

- -

11

Saff

ron

- -

-

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

-

200

ppm

m

axi-

mum

- -

-

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

(b)

Synt

hetic

1 Po

ncea

4R

-

- -

-

2 C

arm

oisi

ne

- -

- -

3 Er

ythr

osin

e -

- -

-

4 Ta

rtarz

ine

-

- -

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

-

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

Page 324: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7331

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

5 Su

nset

Y

ello

w F

CF

- -

- -

6 In

digo

C

arm

ine

- -

- -

7 B

rillia

nt B

lue

FCF

- -

- -

8 Fa

st G

reen

FC

F -

- -

-

F Fi

rmin

g A

gent

s (S

ingl

y or

in c

ombi

natio

n)

1 C

alci

um

Chl

orid

e 35

0 pp

m

max

i-m

um

350

ppm

m

axi-

mum

- 35

0 pp

m

max

i-m

um

350

ppm

m

axi-

mum

- 35

0 pp

m

max

i-m

um

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

-

2 C

alci

um

Lect

ate

- 35

0 pp

m

max

i-m

um

- -

350

ppm

m

axi-

mum

- 35

0 pp

m

max

i-m

um

- 35

0 pp

m

max

i-m

um

- -

3 C

alci

um

Glu

cona

te

- -

- -

- -

350

ppm

m

axi-

mum

- -

- -

4 C

alci

um

Car

bona

te

- -

- -

- -

- -

- -

-

5 C

alci

um

Bis

ulph

ite

- -

- -

- -

- -

- -

-

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

G

Thi

cken

ing

Age

nts

1 M

odifi

ed

Star

ches

-

- -

- -

- -

- -

- 1%

m/m

m

axi-

mum

- -

- -

- -

- -

-

Page 325: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

734 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

7

Lis

t of

Foo

d A

ddit

ives

in T

herm

ally

Pro

cess

ed V

eget

able

s S.No.

Name of Additives

Canned Tomato

Green Beans/ Wax Bean

Sweet Corn/ Baby Corn

Mushrooms

Green Peas

Carrots

Chestnuts & Chestnut Puree

Niger, Groundnut, Seasame and mustard pastes and other oil seeds paste

Asparagus

Processed Peas

Ladies Finger

Cauliflour

Brinjal

Sweet Potato

Garkin

Spinach

Table Onions

Garlic

Bell Paper

Rajma

All pulses and dals whole and splits

Other vegetables and curried vegetables/ ready-to-eat vegerables

1 2

3 4

5 6

7 8

9 10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

A.

Aci

dify

ing

Age

nts

1 A

cetic

A

cid

GM

P -

GM

P G

MP

- -

- -

GM

P -

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

2 Ci

tric

Aci

d G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P

3 La

ctic

A

cid

GM

P -

- -

- -

- -

GM

P -

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

4 L- Ta

rtaric

A

cid

GM

P G

MP

GM

P G

MP

GM

P G

MP

10 g

/kg

max

imum

10

g/k

g m

axim

um

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

5 M

alic

A

cid

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

B A

ntio

xida

nts (

Sing

ly)

1 A

scor

bic

Aci

d -

- G

MP

GM

P -

- 30

0 pp

m

max

imum

30

0 pp

m

max

imum

GM

P -

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

2 BH

A

3 TB

HQ

4 A

corb

tyl

Palm

itate

200

ppm

max

i-m

um

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

C

CO

LOR

S (C

an b

e use

d sin

gly

or in

com

bina

tion

with

in th

e spe

cifie

d Li

mits

(a)

Nat

ural

: Si

ngly

or i

n co

mbi

natio

n

1.

- -

-

-

- -

- -

200

- -

- -

- -

- -

- -

- -

Page 326: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7351

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

- -

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

3 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

4 -

-

-

- -

-

ppm

m

axi

mum

-

- -

- -

- -

- -

- -

-

5 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

6 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

7 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

8 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

9 -

-

-

- -

- -

- -

- -

- -

- -

- -

-

10

- -

- -

- -

- -

- -

- -

- -

- -

- -

11

- -

200

ppm

m

axi-

mum

200

ppm

m

axi-

mum

- -

- -

200

ppm

m

axi-

mum

- -

- -

- -

- -

- -

- -

(b)

Synt

hetic

1 Po

ncea

4R

-

-

- -

- -

- -

- -

- -

- -

- -

- -

2 Ca

rmoi

sine

-

-

- -

- -

- -

- -

- -

- -

- -

- -

3 Er

ythr

osi

ne

- -

-

- -

- -

- -

- -

- -

- -

- -

-

4 Ta

rtarz

ine

- -

-

- -

- -

- -

- -

- -

- -

- -

-

5 Su

nset

Y

ello

w

FCF

- -

-

- -

- -

- -

- -

- -

- -

- -

-

6 In

digo

Ca

rmin

e -

-

- -

- -

- -

- -

- -

- -

- -

- -

7 Br

illia

nt

Blue

FCF

- -

-

- -

- -

- -

- -

- -

- -

- -

-

8 Fa

st G

reen

FCF

-

200

ppm

m

axi-

mum

-

200

ppm

m

axi-

mum

- -

- -

200

ppm

m

axi-

mum

- -

- -

- -

- -

- -

- -

D

Firm

ing

Age

nts

1 Ca

lciu

m

Chlo

ride

0.80

%

max

to

tal

calc

iu

- 0.

80%

m

ax

tota

l ca

lciu

0.80

%

max

to

tal

- -

- -

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

Page 327: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

736 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

2.

Calc

ium

La

ctat

e -

- -

- -

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

3.

Calc

ium

G

luco

nat

e

- -

- -

- 35

0 pp

m

max

i-m

um

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

350

ppm

m

axi-

mum

4.

Calc

ium

Ca

rbon

ate

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

5.

Calc

ium

Bi

-Su

lpha

te

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

6.

Mon

o Ca

lciu

m

Phos

phat

e

m

ion

(con

tent

(d

ices

, sli

ces,

wed

ges)

0.

45%

m

ax

(who

le

piec

es)

-

m

ion

(con

tent

(d

ices

, sli

ces,

wed

ges)

0.

45%

m

ax

(who

le

piec

es)

calc

ium

io

n (c

onte

nt

(dic

es, sli

ces, w

edge

s)

0.45

%

max

(w

hol

e pi

eces

)

- -

- -

- -

- -

- -

- -

- -

- -

- -

7 A

lum

iniu

m

Pota

ssiu

m

Sulp

hate

-

- -

GM

P G

MP

- -

- -

- -

- -

- -

- -

- -

E Pr

oces

sing

Aid

s

1.

Stan

nous

Ch

lorid

e -

- -

- -

- -

- 25

ppm

m

axi-

mum

- -

- -

- -

- -

- -

- -

-

F Th

icke

ning

Age

nts

1 V

eget

abl

e gu

ms

(sin

gly

or

in

com

bina

tio

n)

- 10

g/kg

m

axim

um

10g/

kg

max

imum

10g/

kg

max

im

um

- -

- G

MP

1%

m/m

m

axim

um

- 10

g/kg

m

axim

um

10g/

kg

max

imu

m

10g/

kg

max

imu

m

10g/

kg m

axi

mum

10g/

kg

max

imu

m

10g/

kg

max

imu

m

10g/

kg m

axi

mum

10g/

kg m

axi

mum

10g/

kg m

axi

mum

10g/

kg m

axi

mum

10g/

kg m

axi

mum

10g/

kg

max

imu

m

(i)

Ara

bic

Gum

-

10

g/kg

10

g/

kg

10

g/kg

-

- -

GM

P 1%

m

/m

- 10

g/k

g m

axim

u10

g/k

g m

axim

u10

g/k

g m

axim

u10

g/

kg

10 g

/kg

max

imu

10 g

/kg

max

imu

10

g/kg

10

g/

kg

10

g/kg

10

g/

kg

10

g/kg

10

g/

kg

max

imu

Page 328: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7371

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

(ii)

Carra

gee

nam

-

- -

- -

(iii)

Gua

r G

um

- -

- -

-

(iv)

Carb

o-bb

eab

Gum

- -

- -

-

(v)

Xan

than

G

um

- -

- -

-

2 A

lgin

ates

(s

ingl

y or

in

co

mbi

nat

ion)

-

- -

- -

i A

mm

oni

um

Alg

inat

es

-

- -

- -

ii Ca

lciu

m

alig

ates

- -

- -

-

iii

Pota

ssiu

m

Alg

inat

es

-

- -

- -

iv

Sodi

um

Alg

inat

es

- -

- -

-

v Pr

opyl

gl

ycol

A

lgin

ate

max

imum

m

axim

um

- -

- -

-

m

m

m

max

im

um

m

m

max

im

um

max

im

um

max

im

um

max

im

um

max

im

um

m

vi

Pect

ines

-

- -

max

im

um

- -

GM

P G

MP

max

imu

m

- -

- -

- -

- -

- -

- -

-

G

Calc

ium

D

isodi

um

et

hyle

ndi

amin

e

20

0 pp

m

max

im

um

150

ppm

m

axim

um

as

so

dium

Page 329: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

738 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

H

Softe

nin

g A

gent

s (S

ingl

y or

in

co

mbi

natio

n)

1.

Sodi

um

bi-

carb

onat

e

- -

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

2.

Sodi

um

Citra

te

- -

- -

- -

- -

- -

- -

- -

- -

- -

- -

-

Page 330: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 739T

able

8

Lis

t of

Foo

d A

ddit

ives

for

use

in f

ood

prod

ucts

Sl.

No.

N

ame

of th

e A

dditi

ves

Tam

arin

d Pu

lp

/Pur

ee &

C

onc.

Synt

hetic

Sy

rups

for

Dis

pens

ers

Tom

ato

Pure

e &

Pas

te

Vin

eger

Car

bona

ted

Frui

t B

ever

ages

or

frui

t drin

ks

Deh

ydra

ted

Frui

ts

Car

bona

ted

Wat

er, S

oftd

rink

conc

. (li

quid

/pow

der)

Deh

ydra

ted

Veg

etab

le

Froz

en

Frui

t/Fru

it Pr

oduc

ts

Froz

en

Veg

etab

les

Frui

t Bas

ed

Bev

erag

e M

ix/P

owde

red

Frui

t Bas

ed

Bev

erag

es

1 2

3 4

5 6

7 8

9 10

11

12

13

A

AC

IDIF

YIN

G A

GE

NT

S (S

ingl

y or

in c

ombi

natio

n)

1 C

itric

Aci

d -

G

MP

-

GM

P

- -

- -

2 Fu

mar

ic A

cid

-

- -

- -

- -

-

3 La

ctic

Aci

d -

G

MP

-

- -

- -

-

4 L-

Tarta

ric A

cid

-

- -

GM

P

- -

- -

5 M

alic

Aci

d -

GM

P

- -

GM

P

-

GM

P

- -

-

GM

P

6 Ph

osph

oric

Aci

ds

- G

MP

in C

ola

beve

rage

s on

ly

- -

- -

GM

P in

Col

a be

vera

ges

only

B

AN

TIC

AK

ING

AG

EN

TS

(Sin

gly

or in

Com

bina

tions

)

1 C

arbo

nate

s of

cal

cium

and

m

agne

sium

-

- -

- -

- -

-

2 Ph

osph

ates

of c

alci

um a

nd

mag

nesi

um

- -

- -

- -

- -

3 Si

licat

es o

f cal

cium

, m

agne

sium

, alu

min

ium

or

sodi

um o

r sili

con

diox

ide

- -

- -

-

2%

max

imum

in

pow

ders

on

ly

-

2%

max

imum

in

po

wde

rs

only

-

-

2% m

axim

um

in p

owde

rs

only

C

AN

TIO

XID

AN

TS

1 A

scor

bic

Aci

d -

GM

P

GM

P

- G

MP

G

MP

G

MP

-

- -

GM

P

D

CO

LO

UR

S (C

an b

e us

ed s

ingl

y or

in c

ombi

natio

n w

ithin

the

spec

ified

lim

its)

(a)

Nat

ural

:

1.

Chl

orop

hyll

- -

- -

- -

2 C

aram

el

- -

- -

- -

3 C

urcu

min

or t

urm

eric

-

200

ppm

m

axim

um

-

GM

P C

aram

el

only

100

ppm

m

axim

um

-

100

ppm

m

axim

um

- -

-

200

ppm

m

axim

um

Page 331: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

740 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

4 B

eta-

caro

tene

-

- -

- -

-

5 B

eta

apo-

8 ca

rote

nal

- -

- -

- -

6 M

ethy

lest

er o

f Bet

a-ap

o-8

caro

teni

c ac

id

- -

- -

- -

7 Et

hyle

ster

of B

eta-

apo-

8 ca

rote

nic

acid

-

- -

- -

-

8 C

anth

axan

thin

-

- -

- -

-

9 R

ibof

lavi

n, L

acto

flavi

n -

- -

- -

-

10

Ann

atto

-

- -

- -

-

11

Saff

ron

- -

- -

- -

(b)

Synt

hetic

1 Po

ncea

u 4R

-

- -

- -

- -

2 C

arm

oisi

ne

- -

- -

- -

-

3 Er

ythr

osin

e -

- -

- -

- -

4 Ta

rtarz

ine

- -

- -

- -

-

5 Su

nset

Yel

low

FC

F -

- -

- -

- -

6 In

digo

Car

min

e -

- -

- -

- -

7 B

rilli

ant b

lue

FCF

- -

- -

- -

-

8 Fa

st g

reen

FC

F -

200

ppm

m

axim

um

- -

100

ppm

m

axim

um

-

100

ppm

m

axim

um

- -

-

200

ppm

m

axim

um

E

FL

AV

OU

RS

1 N

atur

al F

lavo

urin

g an

d N

atur

al F

lavo

urin

g su

bsta

nces

/ N

atur

e id

entic

al fl

avou

ring

subs

tanc

es /

artif

icia

l fla

vour

ing

subs

tanc

es

- G

MP

- -

GM

P -

GM

P -

- -

GM

P

F PR

ESE

RV

AT

IVE

S (S

ingl

y or

in c

ombi

natio

n)

1 B

enzo

ic A

cid

and

its S

odiu

m,

Pota

ssiu

m S

alt o

r bot

h (C

alcu

late

d as

Ben

zoic

Aci

d)

750

ppm

m

axim

um

500

ppm

m

axim

um

250

ppm

m

axim

um in

Pu

ree

- 12

0 pp

m

max

imum

-

120

ppm

m

axim

um

- -

- -

2 Su

lphu

r di-o

xide

-

350

ppm

m

axim

um

750

ppm

m

axim

um in

Pa

ste

- 70

ppm

m

axim

um

700

ppm

m

axim

um

70 p

pm

max

imum

20

00 p

pm

max

imum

- -

120

ppm

m

axim

um

Page 332: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7411

2 3

4 5

6 7

8 9

10

11

12

13

3 So

rbic

aci

d its

Na,

K a

nd C

a sa

lts (c

alcu

late

d as

sor

bic

acid

)

30

0 pp

m

max

G

THIC

KEN

ING

AG

ENTS

/STA

BILI

SIN

G/E

MU

LSIF

YIN

G A

GEN

TS

1 V

eget

able

Gum

s (S

ingl

y or

in

com

bina

tion)

G

um A

rabi

c -

GM

P

- -

GM

P

- G

MP

-

- -

GM

P

2 A

lgin

ates

(sin

gly

or in

co

mbi

natio

n

(i)

Cal

cium

Alg

inat

es

- -

- -

- -

- -

-

(ii)

Pota

ssiu

m A

lgin

ates

-

- -

GM

P

- -

- -

-

(iii)

Sodi

um A

lgin

ates

-

GM

P

- -

- -

GM

P

- -

- -

3 Pe

ctin

es

- G

MP

-

- -G

MP

- G

MP

-

- -

GM

P

4 Es

terg

um

- 45

0 pp

m

max

imum

100

ppm

m

ax

- 10

0 pp

m

max

imum

- -

- 10

0 pp

m

max

imum

5 X

anth

an G

um

- 0.

5%

max

imum

- 0.

5%

max

imum

-

- -

0.5%

m

axim

um

6 A

lgin

ic A

cid

- G

MP

-

- G

MP

-

GM

P

- -

- G

MP

7 Q

uini

ne (A

s Su

lpha

te)

- 45

0 pp

m m

ax.

subj

ect t

o 10

0 pp

m in

read

y to

ser

ve

beve

rage

afte

r di

lutio

n

- -

- -

100

ppm

m

axim

um

- -

- 10

0 pp

m

max

imum

8 G

ella

n G

um

GM

P

GM

P

H

Phos

foru

s Pe

nta

Oxi

de

- -

- 50

0 pp

m

max

imu

m

- -

- -

- -

-

I N

itroz

en

- -

- 40

0 pp

m

max

imu

m

- -

- -

- -

-

J Se

ques

tran

t

1

Sodi

um h

exa

met

a ph

osph

ate

- -

- -

-100

0 pp

m

max

-

100

ppm

max

in

car

bona

ted

wat

er o

nly.

- -

- -

Page 333: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

742 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

9

Lis

t of

foo

d ad

diti

ves

for

use

in f

ood

prod

ucts

Sl.

No.

N

ame

of

Add

itive

s

Can

did

Cry

stal

lised

&

Gla

zed

Frui

t

Mur

abba

/Pre

serv

e

Squa

shes

, C

rush

es,

Frui

t Sy

rups

, Sh

arba

ts,

Car

dial

and

B

arle

y W

ater

Gin

ger

Coc

ktai

l (G

inge

r Bee

r an

d G

inge

rale

)

Frui

t /ve

geta

ble

Juic

e, P

ulp,

Pu

ree,

with

pr

eser

vativ

es

for i

ndus

trial

us

e on

ly

Con

cent

rate

d Fr

uit/

Veg

Ju

ice,

Pul

p Pu

ree

with

pr

eser

vativ

es

for i

ndus

trial

us

e on

ly

Che

rry

(Tha

rmal

ly

Proc

esse

d)

Chu

tney

Fr

uits

and

/ or

V

eget

able

/ M

ango

C

hutn

ey

Man

go

Pulp

/Pur

ee

Frui

t Pu

lp/P

uree

Pi

ckle

s

Gre

en C

hilli

Pa

ste,

Gin

ger

Past

e, G

arlic

Pa

ste,

Oni

on

Past

e, W

hole

C

hilli

Pas

te

1 2

3 4

5 6

7 8

9 10

11

12

13

14

A

AC

IDIF

YIN

G A

GE

NT

S (S

ingl

y or

in c

ombi

natio

n)

1 A

cetic

Aci

d -

- -

GM

P G

MP

GM

P -

GM

P -

GM

P G

MP

GM

P

2 C

itric

Aci

d G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P

3 La

ctic

Aci

d G

MP

- G

MP

GM

P G

MP

GM

P -

GM

P -

- -

GM

P

4 L-

Tarta

ric

Aci

d G

MP

GM

P G

MP

GM

P -

- -

GM

P -

- -

GM

P

5 M

alic

Aci

d G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P G

MP

GM

P

6 Ph

osph

oric

A

cids

-

- -

- -

- -

GM

P G

MP

GM

P -

GM

P

B

AN

TIF

OA

MIN

G A

GE

NT

S

1 D

imet

hyl

Poly

silo

xane

-

- -

- -

- -

10 p

pm

max

imum

-

- -

GM

P

2

Mon

o an

d di

glyc

erid

es o

f fa

tty a

cids

and

ed

ible

oils

- -

- -

- -

- 10

ppm

m

axim

um

- -

- G

MP

C

AN

TIO

XID

AN

TS

1 A

scor

bic

Aci

d -

GM

P G

MP

GM

P G

MP

GM

P -

GM

P -

GM

P -

GM

P

D

CO

LO

UR

S (C

an b

e us

ed s

ingl

y or

in c

ombi

natio

n w

ithin

the

spec

ified

lim

its)

(a)

Nat

ural

:

1 C

hlor

ophy

ll -

- -

- -

-

2 C

aram

el

200

ppm

m

axim

um

-

200

ppm

m

axim

um

(on

dilu

tion

exce

pt

200

ppm

m

axim

um

(clu

bbed

fr

om a

1 to

a1

1)

- -

200

ppm

m

axim

um

(c

lubb

ed

from

a1

GM

P (c

lubb

ed

from

a1

to

a11)

GM

P

Page 334: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7431

2 3

4 5

6 7

8 9

10

11

12

13

14

3 C

urcu

min

or

turm

eric

-

- -

4 B

eta-

caro

tene

-

- -

- -

-

5 B

eta

apo-

8 ca

rote

nal

- -

- -

- -

6 M

ethy

lest

er o

f B

eta-

apo-

8 ca

rote

nic

acid

-

- -

- -

-

7 Et

hyle

ster

of

Bet

a ap

o-8

caro

teni

c ac

id

- -

- -

- -

8 C

anth

axan

thin

-

- -

- -

-

9 R

ibof

lavi

n,

Lact

ofla

vin

- -

- -

- -

10

Ann

atto

-

- -

- -

-

11

Saff

ron

-

cord

ial

and

barle

y w

ater

) (c

lubb

ed

from

a1

to

a11)

- -

to a

11)

- -

-

(b)

Synt

hetic

1 Po

ncea

4R

-

- -

- -

- -

-

2 C

arm

oisi

ne

- -

- -

- -

- -

3 Er

ythr

osin

e -

- -

- -

- -

-

4 Ta

rtarz

ine

- -

- -

- -

- -

5 Su

nset

Yel

low

FC

F -

- -

- -

- -

-

6 In

digo

C

arm

ine

- -

- -

- -

- -

7 B

rillia

nt B

lue

FCF

- -

- -

- -

- -

8 Fa

st g

reen

FC

F

200

ppm

m

axim

um

-

200

ppm

m

axim

um

200p

pm

max

imum

- -

200

ppm

m

axim

um

- -

- -

-

E

FIR

MIN

G A

GE

NT

S (S

ingl

y or

in C

ombi

natio

n)

1 C

alci

um

Chl

orid

e G

MP

GM

P -

- -

- 35

0 pp

m

max

imu

350

ppm

m

axim

um

- -

350

ppm

35

0 pp

m

max

imu

Page 335: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

744 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

2 C

alci

um

Lect

ate

GM

P G

MP

- -

- -

- -

3 C

alci

um

Glu

cona

te

GM

P G

MP

- -

- -

- -

4 C

alci

um

Car

bona

te

GM

P G

MP

- -

- -

- -

5 C

alci

um

Bis

ulph

ite

GM

P G

MP

- -

- -

m

only

on

frui

t/veg

eta

ble

piec

es

- -

max

imum

m

onl

y on

frui

t/ ve

geta

ble

piec

es

F FL

AV

OU

RS

1

Nat

ural

Fl

avou

ring

and

Nat

ural

Fl

avou

ring

Subs

tanc

es

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

- -

- -

- -

2

Nat

ure

Iden

tical

Fl

avou

ring

Subs

tanc

es

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

- -

- -

- -

G

PRE

SER

VA

TIV

ES

(sin

gly

or in

com

bina

tion)

1

Ben

zoic

Aci

d &

its

Sodi

um

& P

otas

sium

Sa

lt or

bot

h (C

alcu

late

d as

B

enzo

ic A

cid)

- 20

0 pp

m

max

imum

60

0 pp

m

max

imum

60

0 pp

m

max

imum

60

0 pp

m

max

imum

60

0 pp

m

max

imum

-

250

ppm

m

axim

um

- -

250

ppm

m

axim

um

250

ppm

m

axim

um

2 Su

lphu

r di-

oxid

e

150

ppm

m

axim

um

40 p

pm

max

imum

35

0 pp

m

max

imum

35

0 pp

m

max

imum

1000

ppm

m

axim

um

exce

pt

Che

rry,

St

raw

berr

y,

Ras

pber

ry,

whe

re it

sha

ll be

200

0ppm

m

axim

um.

1500

ppm

m

axim

um

- 10

0 pp

m

max

imum

-

-

100

ppm

m

axim

um

100

ppm

m

axim

um

3 So

rbic

Aci

d C

alci

um

Sorb

ate

and

500

ppm

m

axim

um

500

ppm

m

axim

um

1000

ppm

m

axim

um

200

ppm

m

axim

um

- 10

0 pp

m

max

imum

-

500

ppm

m

axim

um

- -

- 50

0 pp

m

max

imu

m

Page 336: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7451

2 3

4 5

6 7

8 9

10

11

12

13

14

Pota

ssiu

m

Sorb

ate

expr

esse

d as

So

rbic

Aci

d H

PR

OC

ESS

ING

AID

S

1

Sodi

um

Met

abi-

Sulp

hite

as

Sulp

hur

Dio

xide

- -

- -

- -

2000

pp

m

max

imu

m

- -

- -

-

I T

HIC

KE

NIN

G A

GE

NT

S

1 X

anth

an G

um

- -

0.5%

m

axim

um

- -

- -

0.5%

m

axim

um

- -

- 0.

5%

max

imu

m

2 A

lgin

ates

(S

ingl

y or

in

com

bina

tion)

(i)

Am

mon

ium

A

lgin

ates

-

- -

- -

- -

- -

(ii)

Cal

cium

A

lgin

ates

-

- -

- -

- -

- -

(iii)

Pota

ssiu

m

Alg

inat

es

- -

- -

- -

- -

-

(iv)

Sodi

um

Alg

inat

es

- -

- -

- -

- -

-

(v)

Prop

yl g

lyco

l A

lgin

ate

- -

- -

- -

- -

-

3 Pe

ctin

es

- -

GM

P

- -

- -

GM

P

- -

-

GM

P

4 G

ella

n gu

m

GM

P

J SO

FTE

NIN

G A

GE

NT

S (S

ingl

y or

in C

ombi

natio

n)

1 So

dium

Bi-

Car

bona

te

- -

- -

- -

- G

MP

- -

- G

MP

2 So

dium

C

itrat

e -

- -

- -

- -

GM

P -

- -

GM

P

Page 337: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

746 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

10

Lis

t of

foo

d ad

diti

ves

for

use

in F

ood

prod

ucts

Sl.

No.

N

ame o

f A

dditi

ves

Jam

/Jelli

es/F

rui

t Che

ese

Frui

t M

arm

alad

es

Frui

t Ba

r/Tof

fee

Frui

t Ce

real

Fl

akes

Ther

mal

ly

proc

esse

d fru

it be

vera

ges/

Frui

t dr

inks

/read

y to

serv

e fru

itbe

vera

ges

Tom

ato

Ket

chup

Cu

linar

y Pa

ste/O

ther

Sa

uces

Soya

bean

Sa

uce

Soup

s So

up p

owde

r, Fr

uit p

owde

r, V

eget

able

po

wde

r, In

stant

Fr

uit/V

eget

able

Ch

utne

y M

ixed

(d

ry),

Culin

ary

Pow

der,

Seas

onin

g M

ixed

Po

wde

r

Nec

tars

Fr

uit J

uice

s as

pect

ical

y pa

cked

Veg

etab

le

Juic

es

Conc

entra

ted

Frui

t/Veg

. Ju

ice

/Pul

p/Pu

ree

1 2

3 4

5 6

7 8

9 10

11

12

13

14

15

16

A

AC

IDIF

YIN

G A

GEN

TS (S

ingl

y or

in co

mbi

natio

n)

1 A

cetic

Aci

d -

- -

- -

GM

P

GM

P

GM

P

- -

- -

- -

2 Ci

tric A

cid

GM

P

GM

P

GM

P

- G

MP

G

MP

G

MP

G

MP

G

MP

G

MP

G

MP

G

MP

G

MP

G

MP

3 Fu

mar

ic A

cid

GM

P

GM

P

GM

P

- G

MP

0.

3%

max

imum

0.

3%

max

imum

-

- -

- -

- -

4 La

ctic

Aci

d -

- -

- -

GM

P

GM

P

GM

P

GM

P

GM

P

- -

GM

P

GM

P

5 L-

Tarta

ric

Aci

d G

MP

G

MP

G

MP

-

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

-

6 M

alic

Aci

d G

MP

G

MP

G

MP

-

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

7 Ph

osph

oric

A

cids

-

- -

- -

- -

- -

- -

- G

MP

-

B A

NTI

CA

KIN

G A

GEN

TS (S

ingl

y or

in co

mbi

natio

n)

1 Ca

rbon

ates

of

Calc

ium

and

Mag

nesiu

m

- -

- -

- -

- -

- -

- -

-

2 Ph

osph

ates

of

calc

ium

and

Mag

nesiu

m

- -

- -

- -

- -

- -

- -

-

3 Si

licat

es o

f ca

lciu

m,

mag

nesiu

m,

alum

iniu

m o

r so

dium

or

- -

- -

- -

- -

-

2% m

axim

um

- -

- -

Page 338: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7471

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

silic

on d

ioxi

de

C A

NTI

FOA

MIN

G A

GEN

TS

1 D

imet

hyl

Poly

silox

ane

10pp

m

max

imum

10

ppm

m

axim

um

- -

- -

10pp

m

max

imum

-

- -

- -

- 10

ppm

m

axim

um

2 M

ono-

and

digl

ycer

ides

of

fatty

Aci

ds o

f ed

ible

oils

GM

P

GM

P

- -

- -

10pp

m

max

imum

-

- -

- -

- 10

ppm

m

axim

um

D A

NTI

OX

IDA

NTS

1 A

scor

bic A

cid

GM

P

GM

P

GM

P

- G

MP

G

MP

G

MP

-

GM

P

GM

P

GM

P

GM

P

GM

P

GM

P

2 BH

A

- -

- -

- -

- -

- -

-

3 TB

HQ

-

- -

- -

- -

- -

- -

4 A

scro

byl

palm

itate

-

- -

- -

-

200

ppm

m

axim

um

-

200

ppm

m

axim

um

200

ppm

m

axim

um

- -

- -

E.

CO

LOU

RS

(Can

be u

sed

singl

y or

in co

mbi

natio

n w

ithin

the s

peci

fied

limits

)

(a)

Nat

ural

:

1 Ch

loro

phyl

l -

- -

- -

2 Ca

ram

el

- -

- -

-

3 Cu

rcum

in o

r tu

rmer

ic

- -

- -

-

4 Be

ta-c

arot

ene

- -

- -

-

5 Be

ta ap

o-8

caro

tena

l -

- -

- -

6 M

ethy

leste

r of

Beta

-apo

-8

caro

teni

c aci

d

- -

- -

-

7 Et

hyle

ster o

f Be

ta ap

o-8

caro

teni

c aci

d

- -

- -

-

8 Ca

ntha

xant

hin

- -

- -

-

9 Ri

bofla

vin,

La

ctof

lavi

n

GM

P

GM

P

GM

P

-

GM

P

-

GM

P fo

r Ca

ram

el

only

GM

P

GM

P

GM

P

100

ppm

m

ax-

- -

-

Page 339: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

748 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

10

Ann

atto

-

- -

- -

11

Saffr

on

- -

- -

-

(b)

Synt

hetic

1 Po

ncea

4R

- -

- -

- -

- -

2 Ca

rmol

sine

- -

- -

- -

- -

3 Er

ythr

osin

e -

- -

- -

- -

-

4 Ta

rtarz

ine

- -

- -

- -

- -

5 Su

nset

Yel

low

FC

F -

- -

- -

- -

-

6 In

digo

Ca

rmin

e -

- -

- -

- -

-

7 Br

illia

nt B

lue

FCF

- -

- -

- -

- -

8 Fa

st gr

een

FCF

200

ppm

m

axim

um

200

ppm

m

axim

um

100

ppm

m

axim

um

-

100

ppm

m

axim

um

- -

-

100

ppm

m

axim

um

100

ppm

m

axim

um

- -

- -

F FI

RM

ING

AG

ENTS

(Sin

gly

or in

Com

bina

tion)

1 Ca

lciu

m

Chlo

ride

- -

- -

- -

- -

- -

- -

2 Ca

lciu

m

Lect

ate

- -

- -

- -

- -

- -

- -

3 Ca

lciu

m

Glu

cona

te

- -

- -

- -

- -

- -

- -

4 Ca

lciu

m

Carb

onat

e -

- -

- -

- -

- -

- -

-

5 Ca

lciu

m

Bisu

lphi

te

200

ppm

m

axim

um

for u

se o

nly

on th

e fru

it pi

eces

- -

- -

- -

-

350

ppm

m

axim

um

- -

- -

-

G

FLA

VO

UR

S

1 N

atur

al

Flav

ourin

g an

d N

atur

al

Flav

ourin

g su

bsta

nces

/ N

atur

e

GM

P

GM

P

GM

P

- G

MP

-

GM

P

- -

GM

P

Nat

ural

Fl

avou

ring

an

d N

atur

al

Flav

ouri

ng

Subs

tanc

es

GM

P na

tura

l fla

vour

s on

ly

GM

P na

tura

l fla

vour

s on

ly

-

Page 340: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7491

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

iden

tical

fla

vour

ing

subs

tanc

es /

artif

icia

l fla

vour

ing

subs

tanc

es

only

- G

MP

H

FLA

VO

UR

EN

HA

NC

ER

1 M

SG

(Enh

ance

r) -

- -

- -

- G

MP

-

GM

P

GM

P

- -

- -

I PR

ESER

VA

TIV

ES (S

ingl

y or

in co

mbi

natio

n) &

its S

alt

1 Be

nzoi

c Aci

d &

its S

odiu

m

& P

otas

sium

Sa

lt or

bot

h (C

alcu

late

d as

Be

nzoi

c Aci

d)

200

ppm

m

axim

um

200

ppm

m

axim

um

200

ppm

m

axim

um

- 12

0 pp

m

max

imum

750

ppm

m

axim

um

750

ppm

m

axim

um

750

ppm

m

axim

um

- -

-120

ppm

m

ax

- -

-

2 Su

lphu

r di-

oxid

e (Ca

rry

over

from

frui

t pr

oduc

ts)

40 p

pm

max

imum

40

ppm

m

axim

um

100

ppm

m

axim

um

- 70

ppm

m

axim

um-

- -

- 15

00 p

pm

max

imum

-7

0 pp

m

max

-

- -

3 So

rbic

Aci

d an

d its

Cal

., So

d., P

ot. S

alt

(cal

cula

ted

as

Sorb

ic A

cid)

500

ppm

m

axim

um

500

ppm

m

axim

um

500

ppm

m

axim

um

- 30

0 pp

m

max

imum

100

ppm

m

axim

um

100

ppm

m

axim

um

100

ppm

m

axim

um

- -

50pp

m

max

imum

30

0 pp

m

max

- -

-

J PR

OC

ESSI

NG

AID

S

1 N

itrog

en an

d Ca

rbon

diox

ide

- -

- -

- -

- -

- -

- G

MP

G

MP

G

MP

K

THIC

KEN

ING

AG

ENTS

(Sin

gly

or in

com

bina

tion)

1 M

odifi

ed

Star

ches

-

- -

- -

0.5%

m

axim

um

with

de

clar

atio

n on

labe

l

0.5%

m

axim

um

with

de

clar

atio

n on

labe

l

- 0.

5%

max

imum

0.5%

max

imum

of

fin

al fo

od

for

cons

umpt

ion

afte

r dilu

tion

- -

- -

Page 341: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

750 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

2 V

eget

able

G

ums (

Sing

ly

or in

co

mbi

natio

n)

- -

- -

- -

- -

- -

- -

(i)

Ara

bic G

um

- -

- -

- GM

P (fo

r RTS

fru

it be

vera

ges

only

)

- G

MP

-

- -

- -

(ii)

Carra

geen

an

- -

- -

- -

GM

P

- -

- -

-

(iii)

Gua

r Gum

-

- -

- -

- G

MP

-

- -

- -

(iv)

Caro

babb

ean

Gum

-

- -

- -

- G

MP

-

- -

- -

(v)

Xan

than

Gum

-

- -

- -

0.5%

m

axim

um

0.5%

m

axim

um

- -

- -

-

3 A

lgin

ates

(S

ingl

y or

in

com

bina

tion)

- -

- -

- -

- -

- -

- -

- -

(i)

Calc

ium

A

lgin

ates

-

(ii)

Pota

ssiu

m

Alg

inat

es

GM

P (fo

r RT

S fru

it be

vera

ges

only

) -

- -

- -

(iii)

Sodi

um

Alg

inat

es

- -

- -

-

(iv)

Prop

yl g

lyco

l A

lgin

ate

- -

- -

-

(v)

Alg

inic

acid

G

MP

GM

P G

MP

GM

P G

MP

4 Pe

ctin

es

GM

P

GM

P

GM

P

GM

P

GM

P (fo

r RT

S fru

it be

vera

ges

only

)-

GM

P

GM

P

GM

P

GM

P

GM

P

-GM

P -G

MP

- -

Page 342: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7511

2 3

4 5

6 7

8 9

10

11

12

13

14

15

16

5 Es

ter G

um

- -

- -

100

ppm

m

ax

- -

- -

- -

- -

-

6 G

ella

n G

ym

- -

- -

GM

P -

- -

- -

- -

- -

L A

rtifi

cial

swee

tene

rs a

nd P

olyo

ls

1 A

sper

tam

e 10

00pp

m

max

imum

10

00pp

m

max

imum

-

- -

- -

- -

- -

- -

-

2 So

rbito

l 30

%

max

imum

30

%

max

imum

-

- -

- -

- -

- -

- -

-

M

SOFT

ENIN

G A

GEN

TS (S

ingl

y or

in co

mbi

natio

n)

1 So

dium

Bi-

Carb

onat

e -

- -

- -

- -

- G

MP

G

MP

-

- -

-

2 So

dium

Ci

trate

-

- -

- -

- -

- G

MP

G

MP

-

- -

-

N

SEQ

UES

TER

AN

T

1 So

dium

he

xam

eta

phos

phat

e

- -

- -

1000

ppm

m

ax

- -

- -

- 10

00 p

pm

max

-

- -

Page 343: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

752 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

11

Lis

t of

Foo

d A

ddit

ives

for

use

in f

ood

prod

ucts

Sl.

No.

N

ame

of F

ood

Add

itive

Ta

ble

Oliv

es

Rai

sins

D

ates

G

rate

d D

esic

cate

d C

ocon

ut

Dry

Fru

its &

N

uts

A.

Aci

dify

ing

Age

nts

(Sin

gly

or in

com

bina

tion)

1.

Citr

ic A

cid

15 g

m/k

g m

axim

um

- -

- -

2.

L-Ta

rtaric

Aci

d 15

gm

/kg

max

imum

-

- -

-

3.

Ace

tic A

cid

GM

P

- -

-

4.

Lact

ic A

cid

15 g

m/k

g m

axim

um

- -

- -

5.

Hyd

roch

loric

Aci

d G

MP

- -

- -

B

Aci

dity

Reg

ulat

ors

1 So

dium

Hyd

roxi

de

GM

P -

- -

-

2.

Pota

ssiu

m H

ydro

xide

G

MP

- -

- -

C

Ant

ioxi

dant

s

1 L-

Asc

orbi

c A

cid

0.2

gm/k

g m

axim

um

- -

- -

D

Pres

erva

tives

1 Su

lphu

r D

ioxi

de,

Sodi

um/

Pota

ssiu

m/

Cal

cium

Su

lphi

te/

bisu

lpha

te/ m

etas

ulph

ite e

xpes

sed

as S

O2

1.

5 gm

/kg

max

imum

onl

y SO

2

- 50

gm

/kg

max

imum

onl

y SO

2

2.0

gm/k

g m

axim

um

2.

Ben

zoic

A

cid/

So

dium

/ Po

tass

ium

B

enzo

ate

expr

esse

d as

B

enzo

ic A

cid

1 gm

/kg

max

imum

-

- -

-

3.

Sorb

ic A

cid/

Sod

ium

/ Pot

assi

um a

scor

bate

exp

ress

ed a

s so

rbic

ac

id

0.5

gm/k

g m

axim

um

- -

- 0.

5 gm

/kg

max

imum

in

dr

ied

apric

ot

E

Col

our

Ret

entio

n/ S

tabi

lisin

g A

gent

s

1.

Ferr

ous

Glu

cona

te

0.15

gm

/kg

max

imum

as

tota

l iro

n -

- -

-

2.

Ferr

ous

Lact

ate

0.15

gm

/kg

max

imum

as

tota

l iro

n -

- -

-

F Fl

avou

rs

1.

Nat

ural

flav

ours

and

nat

ural

flav

ourin

g su

bsta

nces

G

MP

- -

- -

2.

Nat

ure

iden

tical

flav

ourin

g su

bsta

nces

- -

- -

3.

Arti

ficia

l Fla

vour

ing

Subs

tanc

es

-

- -

-

Page 344: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 753G

Fl

avou

r E

nhan

cers

1.

Mon

o-so

dium

glu

com

ate

5.0

gm/k

g m

axim

um

- -

- -

H

Thi

cken

ing

Age

nts

for

Past

es fo

r St

uffin

g O

lives

1.

Sodi

um A

lgin

ates

5.

0 gm

/kg

max

imum

-

- -

-

2.

Xan

than

gum

3.

0 gm

/kg

max

imum

-

- -

-

3.

Car

agre

enan

G

MP

- -

- -

4 C

arob

eean

gum

G

MP

- -

- -

5.

Gua

r gum

G

MP

I Fi

rmin

g A

gent

s fo

r St

uffe

d O

lives

1 C

alci

um C

hlor

ide

- -

- -

2.

Cal

cium

Lac

tate

-

- -

-

3.

Cal

cium

Citr

ate

1.5

gm/k

g m

axim

um a

s C

alci

um io

ns in

st

uffe

d en

d pr

oduc

t

- -

- -

J M

isce

llane

ous

1.

Min

eral

Oil

(foo

d gr

ades

) -

5 gm

/kg

max

imum

-

- -

2.

Sorb

itol

- 5

gm/k

g m

axim

um

GM

P -

-

3.

Gly

cero

l -

G

MP

- -

4.

Dim

ethy

l Pol

ysilo

xane

-

- -

- -

5.

Car

bon

Dio

xide

G

MP

- -

- -

6 N

itrog

en

GM

P -

- -

-

7.

Cul

ture

s of

Lac

tic A

cid

GM

P -

- -

-

Page 345: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

754 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

12

Lis

t of

foo

d ad

diti

ves

for

use

in S

ugar

s an

d Sa

lt

N

ame

of f

ood

addi

tive

Ref

ined

su

gar

Suga

r Ic

ing/

Po

wde

red

suga

r D

extr

ose

Glu

cose

sy

rup

Dri

ed g

luco

se s

yrup

Edi

ble

com

mon

sal

t/ Io

dize

d sa

lt/

Iron

for

tifie

d co

mm

on s

alt

Mis

ri, G

ur,

Jagg

ery,

Pl

anta

tion

whi

te s

ugar

C

ube

suga

r G

olde

n sy

rup

Kha

ndsa

ri s

ugar

(S

ulph

ur

suga

r),

Bur

a su

gar

Kha

nds

ari

suga

r (D

esi)

A

Pre

serv

ativ

e

1 Su

lphu

r di

oxid

e 20

ppm

m

ax

20 p

pm m

ax

70 p

pm

max

40

ppm

m

ax

40 p

pm m

ax "

Sul

phur

di

oxid

e m

ay b

e pr

esen

t in

an a

mou

nt n

ot e

xcee

ding

15

0 pp

m if

the

prod

uct i

s in

tend

ed f

or th

e m

anuf

actu

re o

f co

nfec

tione

ry to

be

sold

un

der

a la

bel a

s sp

ecif

ied

unde

r A

rtic

le 2

2 of

re

gula

tion

4.4.

4.ru

le 4

2(x)

- 70

ppm

m

ax

150

ppm

m

ax

-

B

Ant

icak

ing

agen

ts s

ingl

y or

in c

ombi

nati

on

1 C

arbo

nate

s of

cal

cium

and

m

agne

sium

-

- -

- -

- -

2 Ph

osph

ates

of

Cal

cium

and

M

agne

sium

-

- -

- -

- -

3 Si

licat

es o

f C

alci

um,

Mag

nesi

um, o

r So

dium

or

silic

on d

ioxi

de

- -

- -

- -

-

4

Myr

ista

tes,

Pal

mita

tes

or

Stea

rate

s of

Alu

min

ium

, A

mm

oniu

m, C

alci

um,

Pota

ssiu

m o

r So

dium

-

15g/

kg m

ax,

sing

ly o

r in

co

mbi

natio

n (C

lubb

ed

from

B1

to

B4)

- -

-

20g/

kg m

ax,

sing

ly o

r in

co

mbi

natio

n (C

lubb

ed

from

B1

to

B4)

- -

-

C

Cry

stal

mod

ifie

rs

1

Cal

cium

or

Sodi

um o

r Po

tass

ium

Fer

rocy

anid

e si

ngly

or

in c

ombi

natio

n ex

pres

sed

as F

erro

cyan

ide

- -

- -

- 10

ppm

max

-

- -

Page 346: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 755T

able

13

Lis

t of

foo

d ad

diti

ves

for

use

in C

ocoa

pow

der,

Cho

cola

te, S

ugar

boi

led

conf

ecti

oner

y, C

hew

ing

gum

/ Bub

ble

gum

Sl.

No.

N

ame

of a

dditi

ve

Coc

oa p

owde

r C

hoco

late

- Whi

te,

Milk

, Pla

in,

Com

posi

te, F

illed

Suga

r bas

ed/ S

ugar

free

co

nfec

tione

ry

Loze

nges

C

hew

ing

gum

/ B

ubbl

e gu

m

1 2

3 4

5 6

7

A

Pres

erva

tives

(Sin

gly

or in

com

bina

tion)

1 B

enzo

ic a

cid,

Sod

ium

and

Pot

assi

um b

enzo

ate

1500

ppm

max

1500

ppm

max

15

00pp

m m

ax

- 15

00pp

m m

ax

2 Su

lphu

r dio

xide

20

00 p

pm m

ax

15

0ppm

max

20

00pp

m m

ax

35

0ppm

max

2000

ppm

max

3 So

rbic

aci

d an

d its

Cal

cium

, Sod

ium

, Pot

assi

um S

alts

(C

alcu

late

d as

sor

bic

acid

) 15

00pp

m m

ax

1000

ppm

max

20

00pp

m m

ax

-

1500

ppm

max

4 C

lass

I pr

eser

vativ

e as

list

ed u

nder

REG

ULA

TIO

N

6.1.

4 G

MP

G

MP

G

MP

G

MP

G

MP

B

Ant

icak

ing

agen

ts (S

ingl

y or

in c

ombi

natio

n)

1 C

alci

um p

hosp

hate

-

- -

-

2 Si

licon

dio

xide

-

- -

-

3 So

dium

alu

min

ium

sili

cate

10 p

pm m

ax

(Clu

bbed

from

1 to

3)

- -

10 p

pm m

ax

-

C

Col

ours

(Can

be

used

sin

gly

or in

com

bina

tion

with

in th

e sp

ecifi

ed li

mits

but

with

in th

e sa

m c

lass

, i.e

. eith

er n

atur

al o

r sy

nthe

tic)

(a)

Nat

ural

(sin

gly

or in

com

bina

tion)

1 C

hlor

ophy

ll -

2 C

aram

el

-

3 C

urcu

min

or t

urm

eric

-

4 B

eta

caro

tene

-

5 B

eta

apo-

8 ca

rote

nal

-

6 M

ethy

l est

er o

f Bet

a ap

o-8

caro

teni

n ac

id

-

7 Et

hyl e

ster

of B

eta

apo-

8 ca

rote

nin

acid

-

8 C

anth

axan

thin

-

9 R

ibof

lavi

n, L

acto

flavi

n -

10

Ann

ato

-

11

Saff

ron

-

Max

100

ppm

in

fille

d ch

ocol

ates

onl

y G

MP

G

MP

G

MP

Page 347: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

756 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

(b)

Synt

hetic

col

our

and

inor

gani

c co

lour

ing

mat

ter

(Sin

gly

or in

com

bina

tion)

1 Er

ythr

osin

e -

2 C

arm

oisi

ne

-

3 Po

ncea

u 4R

-

4 Fa

st g

reen

FC

F -

5 In

digo

car

min

e -

6 B

rillia

nt b

lue

FCF

-

7 Su

nset

Yel

low

FC

F -

8 Ta

rtraz

ine

-

Max

100

ppm

in

fille

d ch

ocol

ates

onl

y M

ax 1

00 p

pm

Max

100

ppm

M

ax 1

00 p

pm

9 Ti

tani

um d

ioxi

de

- -

1000

0ppm

max

-

1000

0ppm

max

D

Flav

ours

(Sin

gly

or in

com

bina

tion)

1 N

atur

al fl

avou

r and

Nat

ural

flav

ourin

g su

bsta

nces

/ N

atur

e id

entic

al fl

avou

ring

subs

tanc

es/ A

rtific

ial

flavo

urin

g su

bsta

nces

G

MP

GM

P

G

MP

GM

P

G

MP

2 V

anill

in

- G

MP

GM

P

G

MP

3 Et

hyl v

anill

in

-

1 pp

m m

ax s

ingl

y or

in

com

bina

tion

GM

P

G

MP

GM

P

E

Em

ulsi

fier

(Sin

gly

or in

com

bina

tion)

1 M

ono

and

di g

lyce

rides

of e

dibl

e fa

tty a

cids

G

MP

G

MP

2 Le

cith

in

10 g

m/ k

g m

ax

G

MP

3 A

mm

oniu

m s

alts

of p

hosp

hatid

ic a

cids

10

gm

/ kg

max

4 Su

cros

e es

ters

of f

atty

aci

ds

10 g

m/ k

g m

ax

10 g

m/ k

g m

ax

5 Po

lygl

ycer

ol p

olyr

icin

olea

te

- 5

gm/ k

g m

ax

6 So

rbita

n m

onos

tear

ate

-

7 So

rbita

n Tr

iste

arat

e -

8 Po

lyxy

leth

ylen

e so

rbita

n m

onos

tear

ate

-

10 g

m/ k

g m

ax

9 C

arra

geen

an

- -

10

Mod

ified

sta

rche

s -

-

11

Gly

cero

l -

GM

P

As

prov

ided

in th

e st

anda

rd

As

prov

ided

in

the

stan

dard

s

As

prov

ided

in th

e st

anda

rd

Page 348: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7571

2 3

4 5

6 7

F A

lkal

izin

g ag

ents

(Sin

gly

or o

n co

mbi

natio

n)

1 So

dium

, Pot

assi

um, C

alci

um, M

agne

sium

and

A

mm

oniu

m c

arbo

nate

s C

alci

um c

arbo

nate

: GM

P

-

Cal

cium

car

bona

te

/mag

nesi

um

carb

onat

e: G

MP

2 So

dium

, Pot

assi

um, C

alci

um, M

agne

sium

bi

carb

onat

es a

s K

2CO

3

Cal

cium

bi

carb

onat

e/so

dium

bi

carb

onat

e: G

MP

Sodi

um

bica

rbon

ate:

G

MP

-

3 So

dium

, Pot

assi

um, C

alci

um M

agne

sium

and

A

mm

oniu

m H

ydro

xide

0.5%

max

on

free

co

coa

(Sin

gly

or in

co

mbi

natio

n)

0.5%

max

on

free

co

coa

(Sin

gly

or in

co

mbi

natio

n)

- -

-

G

Neu

tral

isin

g ag

ents

/ Aci

dula

nts

1 Ph

osph

oric

aci

d 2.

5 gm

/kg

as P

2O5

on c

ocoa

frac

tion

2.

5 gm

/kg

max

as

P2O

5

1300

ppm

max

as

P2O

5

- 22

000

ppm

max

as

P2O

5

2 C

itric

aci

d G

MP

G

MP

G

MP

G

MP

G

MP

3 L-

Tarta

ric a

cid

5 gm

/kg

max

5 gm

/kg

max

2000

ppm

max

GM

P

3000

ppm

max

4 So

dium

hex

amet

apho

spha

te

- -

GM

P as

buf

ferin

g ag

ent

-

-

5 M

alic

aci

d -

GM

P

GM

P

GM

P

GM

P

H

Ant

ioxi

dant

s

1 B

HA

-

200

ppm

max

10

0 pp

m m

ax

- 25

0 pp

m m

ax

2 TB

HQ

-

200

ppm

max

10

0 pp

m m

ax

- 25

0 pp

m m

ax

3 To

coph

erol

-

750

ppm

max

500

ppm

max

GM

P

1500

ppm

max

4 A

scor

byl p

alm

itate

-

200

ppm

max

-

- -

5 Pr

opyl

gal

late

-

200

ppm

max

-

- -

6 L-

Asc

orbi

c ac

id

GM

P

GM

P

GM

P

GM

P

GM

P

7 Le

cith

in

GM

P

GM

P

GM

P

GM

P

GM

P

I Je

llyfy

ing

agen

ts

1 G

elat

ine

(Foo

d gr

ade)

-

- -

-

2 A

gar A

gar

- -

- -

3 So

dium

car

boxy

met

hyl c

ellu

lose

- -

GM

P

- -

Page 349: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

758 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

J L

ubri

cant

s

1 Ta

lc

- -

0.2%

max

0.

2% m

ax

2% m

ax

2 Ic

ing

suga

r -

- G

MP

GM

P

G

MP

3 M

iner

al o

il -

- 0.

2% m

ax

0.2%

max

0.

2% m

ax

4 G

lyce

rine

- -

GM

P

GM

P

GM

P

5 Pa

raff

in w

ax o

r liq

uid

Para

ffin

(Foo

d gr

ade)

-

- G

MP

G

MP

G

MP

6 C

alci

um, M

agen

esiu

m, s

odiu

m s

alts

of S

tear

ic a

cid,

st

earic

aci

d (F

ood

grad

e)

- -

GM

P

GM

P

GM

P

K

Mis

cella

neou

s

1 Ph

osph

ated

sta

rch

- -

- -

GM

P

Page 350: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 759T

able

14

Lis

t of

foo

d ad

diti

ves

for

use

in M

ilk p

rodu

cts

Sl.

No.

N

ame o

f add

itive

s

Chee

se/

Slic

ed/

Cut/S

hred

ded

chee

se

Proc

esse

d ch

eese

Proc

esse

d ch

eese

sp

read

All

type

s of

yog

hurts

Ev

apor

ate

d m

ilk

Swee

tene

d co

nden

sed

milk

Bu

tter

Milk

fa

t/But

ter

oil a

nd

Am

hydr

ous

milk

fa

t/ A

nhyd

rou

s but

ter

oil

Milk

po

wde

r an

d Cr

eam

po

wde

r

Ice c

ream

, K

ulfi,

Drie

d ic

ecre

am

mix

, Fro

zen

dess

erts,

M

ilk ic

e, M

ilk lo

llies

; Ic

e can

dy

Case

in

prod

ucts

W

hey

pow

der

Chha

na/

Pane

er

1 2

3 4

5 6

7 8

9 10

11

12

13

14

15

A

Stab

ilize

rs si

ngly

or i

n co

mbi

natio

n ex

pres

sed

as a

nhyd

rous

subs

tanc

es

1 So

dium

, Pot

assiu

m an

d ca

lciu

m ch

lorid

e -

- -

- -

- -

- -

-

So

dium

, Pot

assiu

m an

d ca

lciu

m ca

rbon

ate

- -

- -

- -

- -

- -

So

dium

, Pot

assiu

m an

d ca

lciu

m C

itrat

e -

- -

- -

- -

GM

P

- -

Ca

lciu

m sa

lt of

or

thop

hosp

horic

acid

-

- -

- -

- -

- -

-

Ca

lciu

m sa

lt of

po

lyph

osph

oric

acid

-

- -

- -

- -

- -

-

Po

tass

ium

salt

of

orth

opho

spho

ric ac

id

- -

- -

- -

- G

MP

-

-

Po

tssiu

m sa

lt of

po

lyph

osph

oric

acid

-

- -

- -

- -

GM

P

- -

So

dium

salt

of

orth

opho

spho

ric ac

id

- -

- -

- -

- G

MP

-

-

So

dium

salt

of

poly

phos

phor

ic ac

id

- -

- -

2 g/

kg

singl

y or

3

g/kg

in

com

bin

atio

n m

ax

2 g/

kg

singl

y or

3

g/kg

in

com

bin

atio

n m

ax

- -

Crea

m

pow

der:

3 g/

kg m

ax

Milk

po

wde

r: Ca

lciu

m

chlo

ride,

sodi

um

citra

te,

Sodi

um

salts

of

orth

opho

sph

oric

ac

id an

d po

lyph

osp

horic

acid

(a

s lin

ear

phos

phat

)-3

g/k

g m

ax

- G

MP

-

-

2 Ca

rrage

enan

-

- -

5 g/

kg

max

150

mg/

kg

max

-

- -

- 10

g/k

g m

ax

- -

-

3 So

dium

, Pot

assiu

m,

Calc

ium

and

Am

mon

ium

A

lgin

ates

-

- -

- -

- -

- -

- -

- -

Page 351: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

760 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

4 G

elat

ine

- -

- 10

g/k

g m

ax

- -

- -

- -

- -

-

5 Le

cith

ins

- -

- -

- -

- -

2.5

g/kg

m

ax

- -

- -

6 Pe

ctin

s -

- -

10 g

/kg

max

-

- -

- -

10 g

/kg

max

-

- -

7 So

dium

carb

oxym

ethy

l ce

llulo

se

- -

- 5

g/kg

m

ax

- -

- -

- 10

g/k

g m

ax

- -

-

8 A

gar

- -

- 5

g/kg

m

ax

- -

- -

- 10

g/k

g m

ax

- -

-

9 G

uar g

um

- -

- 5

g/kg

m

ax

- -

- -

- 10

g/k

g m

ax

- -

-

10

Xan

than

gum

-

- -

5 g/

kg

max

-

- -

- -

10 g

/kg

max

-

- -

11

Trag

acan

th g

um

- -

- 5

g/kg

m

ax

- -

- -

- -

- -

-

12

Kar

aya g

um

- -

- 5

g/kg

m

ax

- -

- -

- -

- -

-

13

Furc

ella

ran

- -

- 5

g/kg

m

ax

- -

- -

- 10

g/k

g m

ax

- -

-

14

Prop

ylen

e gly

col a

lgin

ate

- -

- -

- -

- -

- 10

g/k

g m

ax

-

- -

15

a) P

olyg

lyce

rol e

sters

of

fattt

y ac

ids

b) P

olyo

xyet

hyle

ne

sorb

itan

mon

olau

reat

e c)

Pol

yoxy

ethy

lene

so

rbita

n tri

stear

ate

d) P

olyo

xyet

hyle

ne

sorb

itan

mon

oste

arat

e

- -

- -

- -

- -

- 10

g/k

g m

ax

- -

-

16

Mon

o an

d di

gly

cerid

es o

f fa

tty ac

ids

- -

- -

- -

- -

2.5

g/kg

m

ax

10 g

/kg

max

-

- -

17

Met

hyl c

ellu

lose

-

- -

- -

- -

- -

10 g

/kg

max

-

- -

B Th

icke

ner a

nd m

odify

ing

agen

t sin

gly

or in

com

bina

tion

1 M

icro

crys

talli

ne ce

llulo

se

- -

- -

- -

- -

- 10

g/k

g -

- -

Page 352: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7611

2 3

4 5

6 7

8 9

10

11

12

13

14

15

max

C

Mod

ified

star

ched

sing

ly o

r in

com

bina

tion

1 A

cid

treat

ed st

arch

-

- -

- -

- -

- -

- -

- 2

Alk

ali t

reat

ed st

arch

-

- -

- -

- -

- -

- -

- 3

Blea

ched

star

ch

- -

- -

- -

- -

- -

- -

4 D

istar

ch ad

ipat

e ac

etyl

ated

-

- -

- -

- -

- -

- -

-

5 D

istar

ch g

lyce

rol

- -

- -

- -

- -

- -

- -

6 D

istar

ch g

lyce

rol,

acet

ylat

ed

- -

- -

- -

- -

- -

- -

7 D

istar

ch g

lyce

rol,

hydr

oxyp

ropy

l -

- -

- -

- -

- -

- -

-

8 D

istar

ch p

hosp

hate

-

- -

- -

- -

- -

- -

-

9 D

istar

ch p

hosp

hate

, ac

etyl

ated

-

- -

- -

- -

- -

- -

-

10

Dist

arch

pho

spha

te,

hydr

oxyp

ropy

l -

- -

- -

- -

- -

- -

-

11

Mon

osta

rch

phos

phat

e -

- -

- -

- -

- -

- -

- 12

O

xidi

sed

starc

h -

- -

- -

- -

- -

- -

- 13

St

arch

acet

ate

- -

- -

- -

- -

- -

- -

14

Star

ch h

ydro

xypr

opyl

-

- -

- -

- -

- -

30 g

/kg

max

su

bjec

t to

decl

arat

ion

- -

- D

Flav

ours

1 V

anill

a ext

ract

s -

- -

- -

- -

- -

- -

- -

2 V

anill

in

- -

- -

- -

- -

- -

- -

-

3 Et

hyl v

anill

in

- -

- -

- -

- -

- -

- -

-

4

Nat

ural

flav

ours

and

natu

ral f

lavo

urin

g su

bsta

nces

/ Nat

ure

iden

tical

flav

ourin

g su

bsta

nces

/ Arti

ficia

l fla

vour

ing

subs

tanc

es

- -

-

GM

P su

bjec

t to

decl

arat

ion

- -

- -

-

GM

P su

bjec

t to

decl

arat

ion

- -

-

E C

olou

rs (N

atur

al: s

ingl

y or

in co

mbi

natio

n)

1 Cu

rcum

in

100

ppm

m

ax

10

0 pp

m

max

100

ppm

m

ax

-

- -

100p

pm

max

-

- 10

0 pp

m

max

- -

-

Page 353: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

762 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

2 Ri

bofla

vin

100

ppm

m

ax

100

ppm

m

ax

100

ppm

m

ax

- -

-

- -

50 p

pm

max

-

- -

3 Ch

loro

phyl

l 10

0 pp

m

max

10

0 pp

m

max

10

0 pp

m

max

-

- -

-

- .

- -

-

4 Be

ta ca

rote

ne

100

ppm

m

ax

-

- -

- -

100

ppm

m

ax

-

- 10

0 pp

m

max

- -

-

5 Ca

rote

ne (N

atur

al ex

tract

) 10

0 pp

m

max

100

ppm

m

ax

100

ppm

m

ax

- -

- 10

0 pp

m

max

-

- -

- -

-

6 A

nnat

to ex

tract

on

Bixi

n/

Nor

bix

in b

asis

(50:

50

ratio

)

10-5

0 pp

m m

ax

norm

al to

or

ange

co

lour

ed

10-5

0 pp

m m

ax

norm

al to

or

ange

co

lour

ed

10-5

0 pp

m m

ax

norm

al to

or

ange

co

lour

ed

- -

- 20

pp

m

max

-

- 10

0 pp

m

max

- -

-

7 Be

ta ap

o-8

caro

tena

l 35

ppm

m

ax

-

- -

- -

35

ppm

m

ax

-

- 10

0 pp

m

max

- -

-

8 M

ethy

l este

r of B

eta a

po-8

ca

rote

nin

acid

35

ppm

m

ax

-

- -

- -

35

ppm

m

ax

-

- 10

0 pp

m

max

- -

-

9 Et

hyl e

ster o

f Bet

a apo

-8

caro

teni

n ac

id

- -

- -

- -

- -

- -

- -

-

10

Cant

haxa

nthi

n -

- -

- -

- -

- -

100

ppm

m

ax

-

- -

11

Cara

mel

colo

urs (

Plai

n)

- -

- -

- -

- -

- G

MP

-

- -

12

Cara

mel

colo

urs

(Am

mon

ium

Sul

phite

pr

oces

s)

- -

- -

- -

- -

- 3.

0 g/

kg

max

-

- -

E C

olou

rs (S

ynth

etic

: sin

gly

or in

com

bina

tion)

13

a) P

once

au 4

R b)

Car

moi

sine

c) E

ryth

rosin

e d)

Tar

trazi

ne

e) S

unse

t yel

low

FCF

f)

Indi

go ca

rmin

e g)

Bril

liant

blu

e FCF

- -

-

100

ppm

m

ax (o

nly

in

flavo

ured

an

d fru

it yo

ghur

t)

- -

- -

- 10

0 pp

m

max

-

- -

Page 354: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7631

2 3

4 5

6 7

8 9

10

11

12

13

14

15

h) F

ast g

reen

FCF

F A

cidi

ty re

gula

tors

1 Ca

lciu

m an

d m

agne

sium

ca

rbon

ates

G

MP

-

- -

- -

- -

- -

GM

P

- -

2 So

dium

bic

arbo

nate

and

Sodi

um ca

rbon

ate

- -

- -

- -

- -

- -

- -

-

3 So

dium

and

Calc

ium

hy

drox

ide

- -

- -

- -

2000

pp

m

max

- -

- 20

00 p

pm

max

-

-

4 So

dium

pho

spha

te

- -

- -

- -

GM

P

- -

- G

MP

-

-

G

Pres

erva

tives

1

Sorb

ic ac

id; S

odiu

m,

Pota

ssiu

m an

d Ca

lciu

m

sorb

ates

expr

esse

d as

so

rbic

acid

3000

ppm

m

ax; f

or

cut,

slice

d,

shre

dded

ch

eese

: 10

00 p

pm

max

3000

ppm

m

ax;

30

00 p

pm

max

;

- -

- -

- -

- -

- 20

00 p

pm

max

2 N

isin

12.5

ppm

m

ax

12

.5 p

pm

max

12.5

ppm

m

ax

-

- -

- -

- -

- -

12.5

ppm

m

ax

3

Prop

ioni

c aci

d; S

odiu

m

and

calc

ium

pro

pion

ate

expr

esse

d as

pro

pion

ic

acid

sing

ly o

r in

com

bina

tion

3000

ppm

m

ax

- -

- -

- -

- -

- -

- 20

00 p

pm

max

H

For s

urfa

ce/ R

ind

trea

tmen

t onl

y

1 So

rbic

acid

; Pot

assiu

m

and

Calc

ium

sorb

ates

ex

pres

sed

as so

rbic

acid

1 g/

kg

max

- -

- -

- -

- -

- -

- -

2 Pi

mar

icin

(nat

amyc

ra)

2 m

g/dm

sq

uare

su

rface

, no

t pr

esen

t in

dept

h of

5

mm

- -

- -

- -

- -

- -

- -

Page 355: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

764 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

I A

ntic

akin

g ag

ent

1

a) C

ellu

lose

b)

Car

bona

tes o

f cal

cium

an

d m

agne

sium

c)

Pho

spha

tes o

f cal

cium

an

d m

agne

sium

d)

Sili

cate

s of c

alci

um,

mag

nesiu

m, a

lum

iniu

m o

r so

dium

; or s

ilico

n di

oxid

e e)

Myr

istat

es, P

alm

itate

s an

d St

eara

tes o

f Al,

K, N

a, Ca

, Am

mon

ium

.

10 g

/kg

max

-

- -

- -

- -

- -

- -

-

J A

cidi

fyin

g ag

ents

sing

ly o

r in

com

bina

tion

1 Ci

tric a

cid

-

40 g

/kg

max

with

em

ulsi-

fiers

40 g

/kg

max

with

em

ulsi-

fiers

- -

- -

- -

GM

P in

clud

ing

sodi

um

pota

ssiu

m

salts

- -

-

2 Ph

osph

oric

acid

-

40 g

/kg

max

with

em

ulsi-

fiers

40 g

/kg

max

with

em

ulsi-

fiers

- -

- -

- -

- -

- -

3 A

cetic

acid

-

40 g

/kg

max

with

em

ulsi-

fiers

40 g

/kg

max

with

em

ulsi-

fiers

- -

- -

- -

GM

P

- -

-

4 La

ctic

acid

-

40 g

/kg

max

with

em

ulsi-

fiers

40 g

/kg

max

with

em

ulsi-

fiers

- -

- -

- -

GM

P in

clud

ing

sodi

um

pota

ssiu

m

salts

- -

-

5

Sodi

um b

icar

bona

te/

Calc

ium

carb

onat

e ex

pres

sed

as an

hydr

ous

subs

tanc

e

-

40 g

/kg

max

with

em

ulsi-

fiers

40 g

/kg

max

with

em

ulsi-

fiers

- -

- -

- -

- -

- -

6 M

alic

acid

(DL-

) -

- -

- -

- -

- -

GM

P

- -

-

7 L-

(+Ta

rtaric

acid

&

Sodi

um/ P

otas

sium

salts

) -

- -

- -

- -

- -

1 g/

kg

max

- -

-

Page 356: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7651

2 3

4 5

6 7

8 9

10

11

12

13

14

15

8 So

dium

hyd

roge

n ca

rbon

ate

- -

- -

- -

- -

- G

MP

-

- -

9

a) S

odiu

m/ P

otas

sium

/ Ca

lciu

m o

rthop

hosp

hate

ex

pres

sed

as P

2O5

b) S

odiu

m/ P

otas

sium

/ Ca

lciu

m p

olyp

hosp

hate

ex

pres

sed

as P

2O5

- -

- -

- -

- -

-

2 g/

kg

max

sin

gly

or

in

com

bina

tion

with

as

P2O

5

- -

-

K

Emul

sifie

rs si

ngly

or i

n co

mbi

natio

n

1

a) P

otas

sium

salt

of

mon

o/di

and

poly

phos

phor

ic ac

id

b) C

alci

um sa

lt of

mon

o/di

an

d po

lyph

osph

oric

acid

c)

Sod

ium

salt

of m

ono/

di

and

poly

phos

phor

ic ac

id

- -

- -

- -

- -

- -

-

2 a)

Sod

ium

citra

te

b) P

otas

sium

citra

te

c) C

alci

um ci

trate

-

- -

- -

- -

- -

- -

3

a) C

itric

acid

with

sodi

um

hydr

ogen

carb

onat

e and

or

calc

ium

carb

onat

e b)

Pho

spho

ric ac

id w

ith

sodi

um h

ydro

gen

carb

onat

e and

or c

alci

um

carb

onat

e

-

40 g

/kg

max

ex

cept

th

at ad

ded

phos

phor

us

com

poun

d sh

ould

no

t ex

ceed

9

g/kg

ca

lcul

ated

as

Ph

osph

orus

(C

lubb

ed

toge

ther

frm

1 to

3)

40 g

/kg

max

ex

cept

th

at ad

ded

phos

phor

us co

mpo

und

shou

ld n

ot

exce

ed 9

g/

kg

calc

ulat

ed

as

Phos

phor

us (C

lubb

ed

toge

ther

frm

1 to

3)

- -

- -

- -

- -

- -

L A

ntio

xida

nt si

ngly

or i

n co

mbi

natio

n

1 L-

Asc

orbi

c aci

d -

- -

- -

- -

- 0.

5 g/

kg

max

-

- -

-

2 A

scor

byl p

alim

tate

A

scor

byl s

tear

ate

- -

- -

- -

- 50

0 pp

m

max

0.5

g/kg

m

ax as

as

corb

ic

acid

onl

y in

crea

m

pow

der

- -

- -

3 A

lpha

toco

pher

ols,

Mix

ed

toco

pher

ols

- -

- -

- -

- -

- -

- -

-

Page 357: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

766 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]1

2 3

4 5

6 7

8 9

10

11

12

13

14

15

4 Pr

opyl

gal

late

-

- -

- -

- -

100

ppm

m

ax

- -

- -

-

5 O

ctyl

gal

late

-

- -

- -

- -

100

ppm

m

ax

-

- -

- -

6 Et

hyl g

alla

te

- -

- -

- -

- 10

0 pp

m

max

- -

- -

-

7 D

odec

yl g

alla

te

- -

- -

- -

- 10

0 pp

m

max

- -

- -

-

8 Bu

tyla

ted

hydr

oxy

aniso

le

- -

- -

- -

- 12

5 pp

m

max

100

ppm

m

ax

- -

- -

M

Ant

ioxi

dant

syne

rgist

s

1 Ci

tric a

cid

- -

- -

- -

- G

MP

G

MP

-

- -

-

N M

iscel

lane

ous

1 G

lyce

rol

- -

- -

- -

- -

- 50

g/k

g m

ax

- -

-

Page 358: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 767A

PP

EN

DIX

B:

Mic

robi

olog

ical

Req

uire

men

ts:

Tab

le 1

M

icro

biol

ogic

al R

equi

rem

ents

for

Sea

Foo

ds

Sl N

o N

ame

of th

e pr

oduc

t To

tal P

late

cou

nt

E. C

oli

Stap

hylo

cocc

us

aure

us

Salm

onel

la &

Sh

igel

la

Vib

ro C

hole

rae

Vib

ro

Para

haem

olyt

icus

C

lost

ridiu

m

perf

ringe

ns

1.

Froz

en s

hrim

ps o

r pra

wns

R

aw

Not

mor

e th

at fi

ve

lakh

s /g

m

Not

mor

e th

an

20/g

m

Not

mor

e th

an 1

00

/ gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

C

ooke

d N

ot m

ore

that

one

la

kh /g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

2.

Froz

en L

obst

ers

R

aw

Not

mor

e th

at fi

ve

lakh

s /g

m

Not

mor

e th

an

20/g

m

Not

mor

e th

an 1

00

/ gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

C

ooke

d N

ot m

ore

that

one

la

kh /g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

3.

Froz

en

Not

mor

e th

at fi

ve

lakh

s /g

m

Not

mor

e th

an

20/g

m

Not

mor

e th

an 1

00

/ gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

4.

Froz

en fi

nfis

h N

ot m

ore

that

five

la

khs

/gm

N

ot m

ore

than

20

/gm

N

ot m

ore

than

100

/ g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

5 Fr

ozen

fish

fille

ts o

r min

ced

fish

flesh

or m

ixtu

res

ther

eof

Not

mor

e th

at fi

ve

lakh

s /g

m

Not

mor

e th

an

20/g

m

Not

mor

e th

an 1

00

/ gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

6 D

ried

Shar

k fin

s N

ot m

ore

than

five

la

khs

/ gm

N

ot m

ore

than

20

/ gm

N

ot m

ore

than

100

/ g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

7.

Salte

d fis

h / d

ried

salte

d fis

h N

ot m

ore

than

fiv

elak

hs /

gm

Not

mor

e th

an 2

0 /

gm

Not

mor

e th

an 1

00

/ gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

8.

Can

ned

finfis

h N

il A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

9.

Can

ned

shrim

p N

il A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

10.

Can

ned

sard

ines

or s

ardi

ne ty

pe

prod

ucts

N

il A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

11

Can

ned

salm

on

Nil

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

12

Can

ned

crab

mea

t N

il A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

13

Can

ned

tuna

and

Bon

ito

Nil

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Page 359: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

768 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]T

able

2*

Mic

robi

olog

ical

Par

amet

er f

or M

ilk P

rodu

cts

Sl

No

Req

uire

men

ts

Ice

crea

m /

Froz

en D

esse

rt /

Milk

Lol

ly /

Ice

Can

dy /

Drie

d Ic

e C

ream

mix

Che

ese

/ Pro

cess

ed C

hees

e /

Che

ese

Spre

ad /

All

othe

r C

hees

es

Evap

orat

ed M

ilk

Swee

tene

d C

onde

nsed

Milk

Swee

tene

d C

onde

nsed

Milk

B

utte

r B

utte

r Oil

/ B

utte

r Fa

t / G

hee

Yog

hurt

/ Dah

i

1 To

tal P

late

Cou

nt

Not

mor

e th

an 2

,50,

000

/ gm

N

ot m

ore

than

50,

000/

gm

Not

mor

e th

an

500

/ gm

N

ot m

ore

than

50

0 / g

m

Not

mor

e th

an

5000

/ gm

N

ot m

ore

than

50

00 /

gm

Not

mor

e th

an

10,0

0,00

0 / g

m

2 C

olifo

rm C

ount

N

ot m

ore

than

10/

gm

Abs

ent i

n 0.

1 gm

A

bsen

t in

0.1

gm

Abs

ent i

n 0.

1 gm

N

ot m

ore

than

5/g

mA

bsen

t in

1.0

gm

Not

mor

e tha

n 10

/gm

3

E. C

oli

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1.

0 gm

4

Salm

onel

la

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

5

Shig

ella

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

6 St

aphy

loco

ccus

au

reus

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

10

0 / g

m

Not

mor

e th

an

100

/ gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

10

0/gm

7

Yea

st a

nd M

ould

C

ount

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

10

/ gm

N

ot m

ore

than

20

/ gm

A

bsen

t in

1 gm

N

ot m

ore

than

10

0/gm

8

Ana

erob

ic S

pore

C

ount

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

5 /

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

9 Li

ster

ia

mon

ocyt

ogen

s A

bsen

t in

1 gm

C

hees

e ot

her t

han

hard

ch

eese

: A

bsen

t in

25 g

m

Har

d ch

eese

: Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

*The

abo

ve m

enti

oned

sta

ndar

ds a

re d

efer

red

till 6

th S

epte

mbe

r 20

10 a

nd w

ill b

e en

forc

ed a

fter

7th

Sep

tem

ber,

201

0.

Sl

No

Req

uire

men

ts

Milk

pow

der /

C

ream

Pow

der /

W

hey

pow

der

Edib

le C

asei

n Pr

oduc

ts

UH

T M

ilk /

UH

T fla

vour

ed M

ilk

Past

euris

ed M

ilk /

Boi

led

/ Pas

teur

ised

Fl

avou

red

milk

Ster

ilize

d M

ilk /

Ster

ilize

d Fl

avou

red

Milk

Kho

ya /

Chh

ana

/ Pa

neer

C

hakk

a / S

rikha

nd

1 To

tal P

late

Cou

nt

Not

mor

e th

an

50,0

00 /

gm

Not

mor

e th

an

50,0

00 /

gm

N

il

Not

mor

e th

an

30,0

00 /

gm

N

il N

ot m

ore

than

50

,000

/ gm

N

ot m

ore

than

50

,000

/ gm

2

Col

iform

Cou

nt

Abs

ent i

n 0.

1 gm

A

bsen

t in

0.1

gm

Abs

ent i

n 0.

1 gm

A

bsen

t in

0.1

gm

Abs

ent i

n 0.

1 gm

N

ot m

ore

than

90

/ gm

N

ot m

ore

than

10

/ gm

3

E. C

oli

Abs

ent i

n 0.

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

4

Salm

onel

la

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

5

Shig

ella

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

6 St

aphy

loco

ccus

aur

eus

Abs

ent i

n 0.

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

10

0 / g

m

Not

mor

e th

an

100

/ gm

7

Yea

st a

nd M

ould

Cou

nt S

hrik

hand

: N

ot m

ore

than

50

/ gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

A

bsen

t in

1 gm

N

ot m

ore

than

25

0 / g

m

Cha

kka:

Not

m

ore

than

10

/ gm

8

Ana

erob

ic S

pore

Cou

nt

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Not

mor

e th

an 5

/gm

Abs

ent i

n 1

gm

Not

mor

e th

an 5

/gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

9 Li

ster

ia m

onoc

ytog

ens

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Abs

ent i

n 1

gm

Page 360: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 769T

able

3

Mic

robi

olog

ical

Par

amet

er f

or S

pice

s

Sl

No

Req

uire

men

ts

Car

away

(S

hiah

jira)

C

ardo

mom

(Ela

ichi

) C

hilli

es a

nd C

apsi

cum

(L

al M

irchi

) C

inna

mon

(d

alch

ini)

Cas

sia

(Taj

) C

love

s (L

aung

) C

oria

nder

(D

hani

a)

1 To

tal P

late

Cou

nt

-

-

-

-

-

-

-

2 C

olifo

rm C

ount

-

-

-

-

-

-

-

3 E.

Col

i

-

-

-

-

-

-

-

4 Sa

lmon

ella

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

5 Sh

igel

la

-

-

-

-

-

-

-

6 St

aphy

loco

ccus

aur

eus

-

-

-

-

-

-

-

7 Y

east

and

Mou

ld C

ount

-

-

-

-

-

-

-

8 A

naer

obic

Spo

re C

ount

-

-

-

-

-

-

-

9 Li

ster

ia m

onoc

ytog

ens

-

-

-

-

-

-

-

Sl N

o R

equi

rem

ents

C

umin

(Zee

ra,

Kal

aunj

i) Fe

nnel

(Sau

nf)

Fenu

gree

k (M

ethi

) G

inge

r (So

nth,

A

drak

) M

ace

(Jai

patri

) M

usta

rd (R

ai,

Sars

on)

Nut

meg

(J

aiph

al)

1 To

tal P

late

Cou

nt

- -

- -

- -

-

2 C

olifo

rm C

ount

-

- -

- -

- -

3 E.

Col

i -

- -

- -

- -

4 Sa

lmon

ella

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

5 Sh

igel

la

- -

- -

- -

-

6 St

aphy

loco

ccus

aur

eus

- -

- -

- -

-

7 Y

east

and

Mou

ld C

ount

-

- -

- -

- -

8 A

naer

obic

Spo

re C

ount

-

- -

- -

- -

9 Li

ster

ia m

onoc

ytog

ens

- -

- -

- -

-

Page 361: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

770 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Sl

N

o R

equi

rem

ents

Pe

pper

Bla

ck

(Kal

imirc

h)

Popp

y (K

has

Kha

s)

Saff

ron

(Kes

ar)

Turm

eric

(Hal

di)

Cur

ry P

owde

r M

ixed

Mas

ala

Ani

seed

(Sau

nf)

1 To

tal P

late

Cou

nt

- -

- -

- -

-

2 C

olifo

rm C

ount

-

- -

- -

- -

3 E.

Col

i -

- -

- -

- -

4 Sa

lmon

ella

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

A

bsen

t in

25 g

m

Abs

ent i

n 25

gm

-

- A

bsen

t in

25 g

m

5 Sh

igel

la

- -

- -

- -

-

6 St

aphy

loco

ccus

aur

eus

- -

- -

- -

-

7 Y

east

and

Mou

ld C

ount

-

- -

- -

- -

8 A

naer

obic

Spo

re C

ount

-

- -

- -

- -

9 Li

ster

ia m

onoc

ytog

ens

- -

- -

- -

- Sl

N

o R

equi

rem

ents

A

jow

an (B

isho

ps

seed

)

Drie

d M

ango

Sl

ices

Drie

d M

ango

Po

wde

r (A

mch

ur)

Pepp

er

Whi

te

Gar

lic

(Lah

sun)

C

eler

y D

ehyd

rate

d O

nion

(Suk

ha

Pyaj

) A

safo

etid

a Ed

ible

C

omm

on S

alt

1 To

tal P

late

Cou

nt

- -

- -

-

-

-

2 C

olifo

rm C

ount

-

- -

- -

- -

3 E.

Col

i -

- -

- -

- -

4 Sa

lmon

ella

A

bsen

t in

25 g

m

- -

Abs

ent i

n 25

gm

A

bsen

t in

25

gm

- -

- -

5 Sh

igel

la

- -

- -

-

-

-

6 St

aphy

loco

ccus

aur

eus

- -

- -

-

-

-

7 Y

east

and

Mou

ld C

ount

-

- -

- -

- -

8 A

naer

obic

Spo

re C

ount

-

- -

- -

- -

9 Li

ster

ia m

onoc

ytog

ens

- -

- -

-

-

-

Page 362: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 771T

able

4:

Mic

robi

olog

ical

req

uire

men

ts o

f fo

od p

rodu

cts

give

n be

low

: -

Sl N

o Pr

oduc

ts

Para

met

ers

Lim

its

1.

Ther

mal

ly p

roce

ssed

frui

ts a

nd v

eget

able

pro

duct

s (a

) Tot

al p

late

cou

nt (

b) In

cuba

tion

at

37°C

for 1

0 da

ys a

nd 5

5°C

for 7

day

s (a

) Not

mor

e th

an 5

0 / m

l (b

) No

chan

ges

in p

H

2.

(a) D

ehyd

rate

d fr

uits

and

veg

etab

le p

rodu

cts

(b) S

oup

pow

ders

(c)

Des

icca

ted

coco

nut p

owde

r (d)

Tab

le o

lives

(e) R

aisi

ns (f

) Pis

tach

io

nuts

(g) D

ates

(h) D

ry fr

uits

and

nut

s

Tota

l pla

te c

ount

N

ot m

ore

than

40,

000

/ gm

3.

Car

bona

ted

beve

rage

s, re

ady

– to

– s

erve

bev

erag

es in

clud

ing

frui

t be

vera

ges

(a) T

otal

pla

te c

ount

N

ot m

ore

than

50

cfu

/ ml

(b) Y

east

and

mou

ld c

ount

N

ot m

ore

than

2.0

cfu

/ m

l

(c) C

oli f

orm

cou

nt

Abs

ent i

n 10

0 m

l

4.

Tom

ato

prod

ucts

(a

) Mou

ld c

ount

Po

sitiv

e in

not

mor

e th

an 4

0.0

perc

ent o

f the

fiel

d ex

amin

ed

(a) T

omat

o ju

ices

and

sou

ps

(b) Y

east

and

spo

res

Not

mor

e th

an 1

25 p

er 1

/ 60

c.m

.m

(b

) Tom

ato

pure

e an

d pa

ste

(a) M

ould

cou

nt

Posi

tive

in n

ot m

ore

than

60.

00 p

erce

nt o

f the

fiel

d ex

amin

ed

(a

) Mou

ld c

ount

Po

sitiv

e in

not

mor

e th

an 4

0.00

per

cent

of t

he fi

eld

exam

ined

(b

) Yea

st a

nd s

pore

s

Not

mor

e th

an 1

25 p

er 1

/ 60

c.m

.m

(c) T

omat

o ke

tchu

p an

d To

mat

o Sa

uce

(c )T

otal

pla

te C

ount

N

ot m

ore

than

100

00 /

ml

5.

Jam

/ M

arm

alad

e / F

ruit

jelly

/ Fr

uit C

hutn

ey a

nd S

auce

s To

tal p

late

cou

nt

Posi

tive

in n

ot m

ore

than

40.

00 p

erce

nt o

f the

fiel

d ex

amin

ed

Yea

st a

nd s

pore

s

Not

mor

e th

an 1

25 p

er 1

/ 60

c.m

.m

6.

Oth

er fr

uits

and

veg

etab

les

prod

ucts

cov

ered

und

er it

em A

. 16

of

App

endi

x B

Y

east

and

mou

ld c

ount

Po

sitiv

e in

not

mor

e th

an 1

00 c

ount

/ gm

7.

Froz

en fr

uits

and

veg

etab

les

prod

ucts

To

tal p

late

cou

nt

Not

mor

e th

an 4

0,00

0 / g

m

8.

Pres

erve

s

Mou

ld c

ount

A

bsen

t in

25 g

m /

ml

9.

Pick

les

M

ould

cou

nt

Abs

ent i

n 25

gm

/ m

l

10.

Frui

ts C

erea

l Fla

kes

Mou

ld c

ount

A

bsen

t in

25 g

m /

ml

11.

Can

died

and

Cry

stal

ised

or G

laze

d Fr

uit

and

Peel

M

ould

cou

nt

Abs

ent i

n 25

gm

/ m

l

Page 363: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

772 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]Sl

No

Prod

ucts

Pa

ram

eter

s Li

mits

12.

(i) N

ot m

ore

than

10,

000

cfu

/ gm

for t

hose

pro

duct

s w

hich

hav

e pH

less

than

5.2

(a) F

lat S

our O

rgan

ism

s

(ii) N

il fo

r tho

se p

rodu

cts

whi

ch h

ave

pH m

ore

than

5.2

(b

) Sta

phyl

ococ

cus

aure

us

Abs

ent i

n 25

gm

/ m

l

(c

) Sal

mon

ella

A

bsen

t in

25 g

m /

ml

(d

) Shi

gella

A

bsen

t in

25 g

m /

ml

(e

) Clo

strid

ium

bot

ulin

um

Abs

ent i

n 25

gm

/ m

l

(f

) E. C

oli

Abs

ent i

n 1

gm /

ml

(a) A

ll Fr

uits

and

Veg

etab

le p

rodu

cts

and

read

y –

to –

ser

ve

Bev

erag

es in

clud

ing

Frui

t Bev

erag

es a

nd S

ynth

etic

pro

duct

s co

vere

d un

der A

. 16

of A

ppen

dix

B (

b) T

able

oliv

es (

c) R

aisi

ns

(d) P

ista

chio

nut

s (e

) Dat

es (f

) Dry

frui

ts a

nd n

uts

(g) V

ineg

ars

(g) V

ibrio

Cho

lera

A

bsen

t in

25 g

m/ m

l

Page 364: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 773

Appendix - C FORMS

FORM A

Form of Guarantee (Refer Regulation 10.1)

Invoice No. ................................................. Place:.................................................

From: ................................................. Date: .................................................

To: .................................................

Date of sale Nature and quality of article/brand name, if any

Batch No or Code No.

Quantity Price

1 2 3 4 5

I/We hereby certify that food/foods mentioned in this invoice is/are warranted to be of the nature aqnd quality which it/these purports/purport to be.

Signature of the manufacturer/Distributor/Dealer

Name and address ofManufacturer/Packer .................................................................................................. (in case of packed article)

Licence No. (wherever applicable) .................................................

Page 365: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

774 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

FORM B [Refer Regulation 7.3.8 (2)]

Declaration

I/ We on behalf of .............................................................................................................................. solemnly

declare that the ghee sold by me / us/ on behalf of ........................................................................................./ghee used by

me / us / on behalf of ........................................................................................................................... in the preparation

of ..................................................................... . Confectionary (including sweetmeats) is / was from a tin containing

ghee of ............................................................ origin and having "AGMARK" seal. The said tin pertains to batch

number................................................. from Shri/ Shrimati/ Kumari/ Sarvsri ..................................................................

on the .................................................... as per invoice / cash/ credit memo.

No...................... Dated.......................

Signature of Trader/ Traders

Date..................................

Place.................................

Page 366: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 775

FORM C (Refer regulation 9.1.2)

CERTIFICATE OF ANALYSIS BY THE REFERRAL FOOD LABORATORY

Certificate No. ………..........…………….

Certificate that the sample, bearing number …...................…..purporting to be a sample/of ….....................…….. was received on …...........................……….. with Memorandum No. ……........................................ Dated ……...…….. From …....................................................................…… [Name of the Court] ..........................................………… for analysis. The condition of seals on the container and the outer covering on the receipt was as follows:

……………………………………………………………………..…………………..

…………………………………………………………………………………………

I ………..................................................…….. (name of the Director) ………...........................................…….. found the sample to be ……………..................................….. (Category of food sample) ……………........................… falling under item No. ……….. of Chapter 5 of Food Safety and Standards Regulations, 2010 food. The sample was in a condition fit for analysis and has been analyzed on …….................................…….. (Give date of starting and completion of analysis)……….............................……… and the result of its analysis is given below /*was not in a condition fit for analysis for the reasons given below:-

Reason:-

………………………………………………………………………............................................……………

Analysis Report:-

(i) Sample Description:-......…………………………………………………………

(ii) Physical Appearance :-.....................................………………………………….

(iii) Label: - …………………………………………………………………………

Sl.No. Quality Characteristics

Name of the Method of the test used

Results Prescribed Standards as per:-

(a) Chapter 5

(b) As per label declaration for proprietary foods

(c)As per the provisions of the Act and Regulations, for both above

1.

2.

3.

4.

5.

Options **

Place:....................................... (Signature)

Date:....................................... Director Referral Food Laboratory

(Seal)

Page 367: MINISTRY OF HEALTH AND FAMILY WELFARE - :: Welcome to ALL INDIA

776 THE GAZETTE OF INDIA EXTRAORDINARY [PART III—SEC. 4]

Form D

Report of the Food Analyst (Refer Regulation (ii) of 9.2.1)

Report No...............................

Certified that I ............................................................................. (name of the Food Analyst) duly appointed

under the provisions of Food Safety and Standards Act, 2006 (34 of 2006), for ..............................................................

(name of the local area) received from ..............................* a sample of ................................., bearing Code number and

Serial Number ............................. of Designated Officer of ................................. area* on....................................... (date

of receipt of sample) for analysis.

The condition of seals on the container and the outer co ering on receipt was as follows:

............................................................................................................................................................................

I found the sample to be ..................................... (category of the sample) falling under item No.........................

of Chapter 5 of Food Safety and Standards Regulations, 2010. The sample **was in a condition fit for analysis and

has been analysed on ..................................... (give date of starting and completion of analysis) and the result of its

analysis is given below/** was not in a condition fit for analysis for the reason given below:

Reason:-

………………………………………………………………………............................................……………

Analysis Report:-

(i) Sample Description:-......…………………………………………………………

(ii) Physical Appearance :-.....................................………………………………….

(iii) Label: - …………………………………………………………………………

Sl.No. Quality Characteristics

Name of the Method of the test used

Results Prescribed Standards as per:- (a) Chapter 5 (b) As per label declaration for proprietary foods (c)As per the provisions of the Act and Regulations, for both above

1.

2.

3.

4.

5.

Options ***

Signed this ............................. day of........................ 20..........

(Sd/-) Address:................................................................................... Food Analyst.

* Give the details of the senders ** Strike out whichever is not applicable *** When opinion and interpretation are included, document the basis upon which the opinions/interpretations have been made.

[F.No. 2-15015/30/2010]

V.N. GAUR, Chief Executive Officer


Recommended